Class II FDA device recall · Z-2299-2023

Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.

This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. MULTI-LUMEN CVC BUNDLE KIT, Model Number: ECVC475; b. MULTI-LUMEN CVC INSERTION BUNDLE, Model Number: ECVC3900; c. MULTIMED 16G 1L 20CM CVC STOCK+BUNDLE US, Model Number: STCVC20US; d. MULTIMED 7F 2L 16CM STOCK + BUNDLE US, Model Number: STCVC21US; e. MULTIMED 7F 3L 16CM CVC BUNDLE, Model Number: ECVC6585A; f. MULTIMED 7F 3L 20CM PI, Model Number: ECVC7235A; g. MULTIMED 7FR 16CM CVC STK + BUNDLE-US, Model Number: STCVC03US; h. MULTIMED 7FR 3L 16CM CVC BUNDLE, Model Number: ECVC6655A; i. MULTIMED 7FR 3L 20CM CVC BUNDLE-US, Model Number: ECVC7935; j. MULTIMED 7FR 3L 20CM CVC STK + BUNDLE-US, Model Number: STCVC04US; k. MULTIMED 7FR, 20CM, 3L CVC BUNDLE, Model Number: ECVC7670; l. MULTIMED 8.5F 20CM QUAD CVC BUNDLE, Model Number: ECVC7090; m. MULTIMED 8.5FR 16CM QUAD CVC BUNDLE, Model Number: ECVC6930; n. MULTIMED 8.5FR 2L 16CM CVC STK+BUNDLE-US, Model Number: STCVC13US; o. NEURO CATH PACK (NCLUA)227-LF, Model Number: DYNJ47646D, DYNJ47646F, DYNJ47646G, DYNJ47646I; p. O.R. DOUBLE LUMEN INSERTION TRAY, Model Number: ECVC8010; q. OLEAN GENERAL CVC BUNDLE, Model Number: ECVC4615; r. OR ANGIO PACK, Model Number: DYNJ59184B; s. OR ANGIOGRAM, Model Number: DYNJ909267; t. OR ANGIOGRAPHY DRAPE, Model Number: DYNJ906297D; u. OR ANGIOGRAPHY PACK, Model Numbers: DYNJ67245A, DYNJ67245B; v. OR PERCUTANEOUS CATH PACK, Model Number: DYNJ63372A, DYNJ63372B, DYNJ63372C, DYNJ63372D; w. OR VANTEX 7FR 3L 16CM CVC, Model Number: ECVC6665; x. OR VASCULAR ANGIO PACK, Model Number: DYNJ69763, DYNJ69763A; y. PACK CARDIAC CATH, Model Number: DYNJ65481; z. PACK PERCUTANEOUS ANGIO CHRG, Model Number: DYNJ60112B; aa. PEDIATRIC CATH ANGIO PACK, Model Number: DYNJ54755G, DYNJ54755I; bb. PEDIATRIC CATH PACK-LF, Model Number: DYNJ0843244K; cc. PERCUTANEOUS ANGIO PACK-LF, Model Number: DYNJ57645C; dd. PERCUTANEOUS PACK, Model Number: DYNJ46035C, DYNJ46035D; ee. PERMA CATH PACK, Model Number: DYNJ62007A; ff. PI CVC BUNDLE, VANTEX 3L, 16CM, Model Number: ECVC3665; gg. PI CVC BUNDLE, VANTEX 3L, 20CM, Model Number: ECVC6190; hh. PI VANTEX 7FR 16CM 3L CVC BUNDLE-MAXPLUS, Model Number: ECVC4380; ii. PI VANTEX 7FR 16CM 3L CVC-MicroClave, Model Number: ECVC5655; jj. PI VANTEX 7FR 20CM 3L CVC-MicroClave, Model Number: ECVC5650; kk. PI VANTEX 8.5FR 16CM 4L CVC-MicroClave, Model Number: ECVC5660; ll. PI VANTEX 8.5FR 20CM 4L CVC-MicroClave, Model Number: ECVC5685; mm. PICC LINE PACK-LF, Model Number: DYNJ0275614F; nn. PK, RADIOLOGY, Model Number: DYNJ43894B; oo. PORT A CATH PACK, Model Number: DYNJ59307F; pp. PORT PACK, Model Number: DYNJ58162; qq. PORTACATH PACK, Model Number: DYNJ51240A; rr. QUAD LUMEN CVC BUNDLE 8.5F, 16CM, Model Number: ECVC3700; ss. QUAD LUMEN CVC BUNDLE, 8.5F, 20CM, Model Number: ECVC4995; tt. QUAD LUMEN CVC INSERTION BUNDLE, Model Numbers: ECVC5025, ECVC4135; uu. QUAD LUMEN KIT, Model Number: ECVC5820; vv. RADIOFREQUENCY ABLATION PACK, Model Number: DYNJ65913; ww. RADIOLOGY PACK, Model Numbers: DYNJ41190, DYNJ43894A, DYNJ44087A, DYNJ44524F, DYNJ52806C; xx. RADIOLOGY PACK 108402-LF, Model Number: DYNJVB1000; yy. RR-ADULT ECMO PACK, Model Number: DYNJ69742, DYNJ69742B; zz. SHEATH INTRODUCER BUNDLE, Model Number: ECVC2930, ECVC5835; aaa. SK-ANGIO TRAY-LF, Model Number: DYNJ82030; bbb. SK-INTERVENTIONAL TRAY-LF, Model Number: DYNJ82041; ccc. SPECIAL PROCEDURE CATH LAB PK, Model Number: DYNJ68729; ddd. SPECIAL PROCEDURE PACK, Model Number: DYNJ38314G; eee. SPECIAL PROCEDURE PACK-LF, Model Number: DYNJ0416535AA, DYNJ0416535W, DYNJ0458661C; fff. SPECIAL PROCEDURE PK-LF, Model Number: DYNJ0604508R; ggg. SPECIAL PROCEDURES, Model Number: DYNJ23288C; hhh. STANDARD ANGIO TRAY MV, Model Number: DYNJ67136A; iii. STD, AVA ,3XI ,3L 8.5F KIC, Model Number: ECVC7465A; jjj. STD, AVA, 3L, 9F, HF, KIC, Model Number: ECVC810

Why it was recalled

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

Is your unit affected?

The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.

A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.

Show the FDA's listed lot / code information

All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023:    a. Model Number: ECVC475, UPC Number: 10653160333081.   b. Model Number: ECVC3900, UPC Number: 10653160334828.   c. Model Number: STCVC20US, UPC Number: 10653160339076.   d. Model Number: STCVC21US, UPC Number: 10653160339045.   e. Model Number: ECVC6585A, UPC Number: 10653160338826.   f. Model Number: ECVC7235A, UPC Number: 10653160354550.   g. Model Number: STCVC03US, UPC Number: 10653160339212.   h. Model Number: ECVC6655A, UPC Number:10653160339267.   i. Model Number: ECVC7935, UPC Number: 10653160353669.   j. Model Number: STCVC04US, UPC Number: 10653160339199.   k. Model Number: ECVC7670, UPC Number:10653160348054.   l. Model Number: ECVC7090, UPC Number: 10653160339243.   m. Model Number: ECVC6930, UPC Number:10653160339250.    n. Model Number: STCVC13US, UPC Number: 10653160339137.   o. Model Number: DYNJ47646D, UPC Number: 019348995047; Model Number: DYNJ47646F, UPC Number: 019532715551; Model Number: DYNJ47646G, UPC Number: 019532717502; Model Number: DYNJ47646I, UPC Number: 019532735712.   p. Model Number: ECVC8010, UPC Number: 10653160356356.   q. Model Number: ECVC4615, UPC Number: 10653160336075.   r. Model Number: DYNJ59184B, UPC Number: 019348994910.   s. Model Number: DYNJ909267, UPC Number: 019532731461.   t. Model Number: DYNJ906297D, UPC Number: 019532714128.   u. Model Number: DYNJ67245A, UPC Number: 019532702425; Model Number: DYNJ67245B, UPC Number: 019532729222.   v. Model Number: DYNJ63372A, UPC Number: 019348929205; Model Number: DYNJ63372B, UPC Number: 019348947044; Model Number: DYNJ63372C, UPC Number: 019532708614; Model Number: DYNJ63372D, UPC Number: 019532727047.   w.  Model Number: ECVC6665, UPC Number: 10653160337843.   x. Model Number: DYNJ69763, UPC Number: 019348997737; Model Number: DYNJ69763A, UPC Number: 019532733001.   y. Model Number: DYNJ65481, UPC Number: 019348928046.   z. Model Number: DYNJ60112B, UPC Number: 019532711884.   aa. Model Number: DYNJ54755G, UPC Number: 019348998776; Model Number: DYNJ54755I, UPC Number: 019532702126.   bb.  Model Number: DYNJ0843244K, UPC Number: 019532728859.   cc. Model Number: DYNJ57645C, UPC Number:019532728741.   dd. Model Number: DYNJ46035C, UPC Number: 019348934095; Model Number: DYNJ46035D, UPC Number: 019348949364.    ee. Model Number: DYNJ62007A, UPC Number: 019348987890.   ff. Model Number: ECVC3665, UPC Number: 10653160336044.    gg. Model Number: ECVC6190, UPC Number: 10653160337751.   hh. Model Number: ECVC4380, UPC Number: 10653160338147.   ii. Model Number: ECVC5655, UPC Number: 10653160337621.   jj. Model Number: ECVC5650, UPC Number: 10653160336457.   kk. Model Number: ECVC5660, UPC Number: 10653160337638.   ll. Model Number: ECVC5685, UPC Number: 10653160337652.   mm. Model Number: DYNJ0275614F, UPC Number: 088994217434.   nn. Model Number: DYNJ43894B, UPC Number: 019348981048.   oo. Model Number: DYNJ59307F, UPC Number: 019532705885.   pp. Model Number: DYNJ58162, UPC Number: 088994282933.   qq. Model Number: DYNJ51240A, UPC Number: 088994249352.   rr. Model Number: ECVC3700, UPC Number: 10653160332886.   ss. Model Number: ECVC4995, UPC Number: 10653160335283.   tt. Model Number: ECVC5025, UPC Number: 10653160333142; Model Number: ECVC4135, UPC Number: 10653160335900.   uu. Model Number: ECVC5820, UPC Number: 10653160338123.   vv. Model Number: DYNJ65913, UPC Number: 019348930317.   ww. Model Number: DYNJ41190, UPC Number: 088438989908; Model Number: DYNJ43894A, UPC Number: 088994213269; Model Number: DYNJ44087A, UPC Number: 088994256180; Model Number: DYNJ44524F, UPC Number: 019348946748; Model Number: DYNJ52806C, UPC Number: 019348929290.   xx. Model Number: DYNJVB1000, UPC Number: 019348980099.   yy. Model Number: DYNJ69742, UPC Number: 019348997490; Model Number: DYNJ69742B, UPC Number: 019532713688.   zz. Model Number: ECVC2930, UPC Number: 10653160335368; Model Number: ECVC5835, UPC Number: 10653160333364.   aaa. Model Number: DYNJ82030, UPC Number: 019532716237.   bbb. Model Number: DYNJ82041, UPC Number: 019532716221.   ccc. Model Number: DYNJ68729, UPC Number: 019348983654.   ddd. Model Number: DYNJ38314G, UPC Number: 019348960334.     eee. Model Number: DYNJ0416535AA, UPC Number: 019532735459; Model Number: DYNJ0416535W, UPC Number: 019348956435; Model Number: DYNJ0458661C, UPC Number: 088994255094.   fff. Model Number: DYNJ0604508R, UPC Number: 019348982844.   ggg. Model Number: DYNJ23288C, UPC Number: 019348995414.   hhh.  Model Number: DYNJ67136A, UPC Number: 019348993567.   iii. Model Number: ECVC7465A, UPC Number: 10653160350088.   jjj. Model Number: ECVC8100, UPC Number: 10653160357841.   kkk. Model Number: DYNJ27613J, UPC Number: 019348956435; Model Number: DYNJ27613K, UPC Number: 019532713118.   lll. Model Number: DYNJ80925, UPC Number: 019532708511.   mmm. Model Number: DYNJ52425J, UPC Number: 019348994014.   nnn. Model Number: DYNJ83251, UPC Number: 019532724865.   ooo. Model Number: ECVC7310, UPC Number: 10653160345060; Model Number: ECVC7310A, UPC Number: 10653160352792.   ppp. Model Number: ECVC2965, UPC Number: 10653160338611; Model Number: ECVC3155, UPC Number: 10653160334132; Model Number: ECVC5475, UPC Number: 10653160338116.   qqq. Model Number: ECVC5015, UPC Number: 10653160338956.   rrr. Model Number: ECVC3395, UPC Number: 10653160338635.    sss. Model Number: ECVC5810, UPC Number: 10653160336419.   ttt. Model Number: ECVC255, UPC Number: 10653160331735; Model Number: ECVC5200, UPC Number: 10653160336150.   uuu. Model Number: ECVC825A, UPC Number: 10653160333548.   vvv. Model Number: ECVC7180, UPC Number: 10653160343165.   www. Model Number: ECVC7425, UPC Number: 10653160347699; Model Number: STCVC2040, UPC Number: 10653160336785; Model Number: STCVC2040A, UPC Number: 10653160345701.   xxx. Model Number: ECVC7290, UPC Number: 10653160344933.   yyy. Model Number: ECVC5355B, UPC Number: 10653160357742.   zzz. Model Number: ECVC6020A, UPC Number: 10653160338413.   aaaa. Model Number: ECVC1910, UPC Number:10653160334453; Model Number: ECVC5870A, UPC Number:10653160338383.   bbbb. Model Number: ECVC6055A, UPC Number: 10653160335849.   cccc. Model Number: ECVC6540, UPC Number: 10653160339397.   dddd. Model Number: ECVC3735A, UPC Number: 10653160334798.   eeee. Model Number: ECVC3355, UPC Number: 10653160333982; Model Number: ECVC3400, UPC Number: 10653160340591; Model Number: ECVC3460, UPC Number: 10653160332794; Model Number: ECVC3785, UPC Number: 10653160336006; Model Number: ECVC3810, UPC Number: 10653160336013; Model Number: ECVC4880, UPC Number: 10653160333111; Model Number: ECVC5020, UPC Number: 10653160334903; Model Number: ECVC5020A, UPC Number: 10653160358251; Model Number: ECVC5125, UPC Number: 10653160334934; Model Number: ECVC5270, UPC Number: 10653160336198; Model Number: ECVC6395, UPC Number: 10653160336372.    ffff. Model Number: ECVC1490, UPC Number: 10653160332183; Model Number: ECVC1490A, UPC Number: 10653160359036; Model Number: ECVC1495, UPC Number: 10653160334569; Model Number: ECVC1495A, UPC Number: 10653160358794.   gggg. Model Number: ECVC1710, UPC Number: 10653160332268.   hhhh. Model Number: ECVC5815, UPC Number: 10653160336402.   iiii. Model Number: DYNJ67990A, UPC Number: 019532726533.   jjjj.Model Number: DYNJ41562F, UPC Number: 019348964108.    kkkk. Model Number: DYNJ41562D, UPC Number: 019348958812.   llll. Model Number: ECVC1655, UPC Number: 10653160254935.   mmmm. Model Number: ECVC7170, UPC Number: 10653160333524.   nnnn. Model Number: ECVC6680, UPC Number: 10653160337867; Model Number: ECVC6680A, UPC Number: 10653160337164.   oooo. Model Number: ECVC6675, UPC Number: 10653160337850; Model Number: ECVC6675A, UPC Number: 10653160336617.   pppp. Model Number: ECVC7970, UPC Number: 10653160353980.   qqqq. Model Number: ECVC6815, UPC Number: 10653160335115.   rrrr. Model Number: ECVC6840, UPC Number: 10653160336761.   ssss. Model Number: ECVC6835, UPC Number: 10653160336778.   tttt. Model Number: ECVC7485, UPC Number: 10653160354802.   uuuu. Model Number: ECVC7615, UPC Number: 10653160348009; Model Number: ECVC7690, UPC Number: 10653160348153.    vvvv. Model Number: ECVC6630, UPC Number: 10653160337492.   wwww. Model Number: ECVC6690, UPC Number: 10653160336600.    xxxx. Model Number: ECVC8135, UPC Number: 10653160358558; Model Number: ECVC8160, UPC Number: 10653160358404.   yyyy. Model Number: ECVC7915, UPC Number: 10653160353355.   zzzz. Model Number: ECVC6550, UPC Number: 10653160335276; Model Number: ECVC6595, UPC Number: 10653160337485; Model Number: ECVC7115B, UPC Number: 10653160350279; Model Number: ECVC7275, UPC Number: 10653160342700; Model Number: ECVC7275A, UPC Number: 10653160344292; Model Number: ECVC8015, UPC Number: 10653160355366.   aaaaa. Model Number: ECVC7400, UPC Number: 10193489199956; Model Number: ECVC7960, UPC Number: 10653160353881; Model Number: ECVC8050, UPC Number: 10653160355601.   bbbbb. Model Number: ECVC7945, UPC Number: 10653160353966.   ccccc. Model Number: ECVC7625, UPC Number: 10653160356295.   ddddd. Model Number: ECVC7895, UPC Number: 10653160355328.   eeeee. Model Number: STCVC02US, UPC Number: 10653160336815; Model Number: STCVC02UST, UPC Number: 10653160358589.   fffff. Model Number: ECVC7405, UPC Number: 10653160347132.   ggggg. Model Number: ECVC7295, UPC Number: 10653160344650.   hhhhh. Model Number: ECVC6765, UPC Number: 10653160336839.   iiiii. Model Number: ECVC7495B, UPC Number: 10653160355748.   jjjjj. Model Number: ECVC6505, UPC Number: 10653160336327; Model Number: ECVC7300, UPC Number: 10653160344698.   kkkkk. Model Number: ECVC7560, UPC Number: 10653160347705; Model Number: ECVC7955, UPC Number: 10653160353867; Model Number: ECVC8020, UPC Number: 10653160355458; Model Number: ECVC8045, UPC Number: 10653160355595; Model Number: ECVC8085, UPC Number: 10653160356905.  lllll. Model Number: ECVC8025, UPC Number: 10653160355434.   mmmmm. Model Number: ECVC8040, UPC Number: 10653160355700.   nnnnn. Model Number: ECVC7565, UPC Number: 10653160347682.   ooooo. Model Number: ECVC7830A, UPC Number: 10653160355342.   ppppp. Model Number: STCVC01US, UPC Number: 10653160336846; Model Number: STCVC01UST, UPC Number: 10653160358565.   qqqqq. Model Number: ECVC7630, UPC Number: 10653160347750.   rrrrr. Model Number: ECVC6050A, UPC Number: 10653160335894; Model Number: ECVC6670, UPC Number: 10653160336624; Model Number: ECVC7660, UPC Number: 10653160347804.   sssss. Model Number: ECVC7385, UPC Number: 10653160346210; Model Number: ECVC7385A, UPC Number: 10653160347392; Model Number: ECVC7700, UPC Number: 10653160348375.   ttttt. Model Number: ECVC5595, UPC Number: 10653160336495.   uuuuu. Model Number: ECVC6800, UPC Number: 10653160335092.   vvvvv. Model Number: ECVC7785, UPC Number: 10653160349365.   wwwww. Model Number: ECVC6825A, UPC Number: 10653160336631.   xxxxx. Model Number: ECVC7505A, UPC Number: 10653160352853.   yyyyy. Model Number: ECVC7835A, UPC Number: 10653160355359.   zzzzz. Model Number: ECVC8080, UPC Number: 10653160356899.   aaaaaa. Model Number: STCVC06US, UPC Number: 10653160338314.   bbbbbb. Model Number: ECVC1320, UPC Number: 10653160335795.   cccccc. Model Number: ECVC6255, UPC Number: 10653160336525.   dddddd. Model Number: ECVC6260, UPC Number: 10653160336488.   eeeeee. Model Number: ECVC5080, UPC Number: 10653160337690.   ffffff. Model Number: ECVC6920, UPC Number: 10653160336716; Model Number: ECVC7000, UPC Number: 10193489196399.   gggggg. Model Number: ECVC6915, UPC Number: 10653160336723; Model Number: ECVC6975, UPC Number: 10653160336679.   hhhhhh. Model Number: ECVC4105, UPC Number: 10653160334835.   iiiiii. Model Number: ECVC6340A, UPC Number: 10653160355038.   jjjjjj. Model Number: DYNJ0429121K, UPC Number: 019532706950.   kkkkkk. Model Number: ECVC7330, UPC Number: 10653160345565.

Recall status

Ongoing — the recall is still being carried out.

Where it was distributed

Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.

Recall record

Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product type: Devices
Recall number: Z-2299-2023
Voluntary / mandated: Voluntary: Firm initiated
Initial notification: Letter
Origin: Northfield, IL
Recall initiated: 2023-05-15

What to do

Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.

Also available: structured data (JSON-LD) · recall record (JSON)

What this is — and is not

A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.

To report a problem you experienced, use FDA MedWatch. Verify this record at FDA recalls · Recall Z-2299-2023 · Source: openFDA enforcement.