Class II FDA device recall · Z-2321-2023

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. PEDIATRIC CATH ANGIO PACK, Model Number: DYNJ54755B; b. PEDIATRIC MAX BARRIER KIT-LF, Model Number: DYNJ40306A; c. PERC PACK-LF, Model Number: DYNJ0774759P; d. PERCUTANEOUS VASCULAR CDS, Model Number: DYNJ902261D; e. PERIPHERAL NERVE BLOCK KIT/P, Model Number: DYNJRA1747; f. PERIPHERAL PACK, Model Number: DYNJ44960D; g. PERIPHERAL ULTRASOUND CATHETER, Model Number: DYNDV2285, MNS9865; h. PERIPHERAL VASCULAR GRAFT PACK, Model Number: DYNJ904401B; i. PERMACATH-LF, Model Number: DYNJ42262D; j. PHLEBECTOMY PACK, Model Number: DYNJ47502B; k. PHYSIATRY PACK, Model Number: DYNJ67414; l. PICC INSERT KIT-LESS THAN 3 FR, Model Number: PHS41739A; m. PICC INSERTION PACK, Model Number: DYNJ60038; n. PICC LINE DOUBLE LUMEN CDS, Model Number: CDS982858F; o. PICC LINE INSERTION, Model Number: DYNJ39885A; p. PICC LINE INSERTION WRO-LF, Model Number: DYNJ41873B; q. PICC LINE TRAY, Model Number: DYNJ52688A; r. PICC LINE TRIPLE LUMEN CDS, Model Number: CDS982859F; s. PICC LINEPACK (PCLUI)642-LF, Model Number: DYNJ47717; t. PICC PACK, Model Number: DYNJ55723A, DYNJ60990; u. PICC PROCEDURE PACK, Model Number: DYNJ59067; v. PICC TRAY, Model Number: DYNJ49177F; w. PIV WITH ULTRASOUND KIT, Model Number: DYNDC2399A; x. PK GEN-RECIPIENT, Model Number: DYNJ41114C; y. PK GEN-TRANSPLANT, Model Number: DYNJ54894A; z. PK, GEN-TRANSPLANT, Model Number: DYNJ54894A; aa. PK, GEN-TRANSPLANT-DONOR, Model Number: DYNJ54982A; bb. PORT INSERTION PACK, Model Number: CVI4765; cc. PORT PACK, Model Number: DYNJ56857B, DYNJ68990; dd. POWERGLIDE PLACEMENT KIT, Model Number: DYNDA1468C; ee. PREMIER PROCEDURE PACK, Model Number: DYNJ64393; ff. PREP KIT, Model Number: DYNJRA1155B, DYNJRA1200B; gg. PREP TRAY, Model Number: DYNJRA1498; hh. PROCEDURE PACK, Model Number: DYNJ55063A, DYNJ57674A, DYNJ59795A, DYNJ62588, DYNJ64372, DYNJ64372A, DYNJ68968; ii. PUH AV FISTULA CDS, Model Number: CDS984329J; jj. PURPLE PACK, Model Number: DYNJ62197; kk. PV INTERVENTIONAL PACK-LF, Model Number: DYNJ45757F; ll. PV PACK, Model Number: DYNJ46549J; mm. RAD CVC TRAY, Model Number: DYNJ35574A, DYNJ54131; nn. RAD ONC LITHOTOMY PACK, Model Number: DYNJ60698B; oo. RADIOFREQUENCY ABLATION PACK, Model Number: DYNJ63155A; pp. RADIOLOGY PACK, Model Number: DYNJ42172A; qq. RADIOLOGY PACK-LF #108402, Model Number: DYNJ58225B; rr. RADIOLOGY SPECIALS PACK, Model Number: PHS479840M; ss. RADIOLOGY TRAY, Model Number: MNS11625; tt. RECIPIENT PACK, Model Number: DYNJ41114B; uu. REGIONAL SINGLE SHOT KIT, Model Number: DYNJRA1256; vv. RFA PACK, Model Number: DYNJ57149, DYNJ67899; ww. RIGHT HEART TRAY, Model Number: DYNJ40379C; xx. ROBOT, Model Number: DYNJ906112; yy. ROBOTIC GYN SSC, Model Number: DYNJ60009A; zz. ROBOTIC PROSTATECTOMY, Model Number: DYNJ905826B, DYNJ905826C, DYNJ905826D, DYNJ905826F; aaa. RRMC AORTIC GRAFT PACK-2, Model Number: DYNJ33546J; bbb. RR-SPECIAL PROCEDURE PACK-LF, Model Number: DYNJ0785821M, DYNJ0785821N, DYNJ0785821O; ccc. SCLEROTHERAPY KIT, Model Number: DYNJ62434A; ddd. SLUH LIVER TRANSPLANT PACK-LF, Model Number: DYNJ0369434M; eee. SMH VASCULAR CDS, Model Number: CDS984584L; fff. SPECIAL PROCEDURE PACK, Model Number: DYNJ53135B, DYNJ53135C; ggg. SPECIAL PROCEDURE PACK-LF, Model Number: DYNJ0416535U, DYNJ0416535Y; hhh. SPECIALS PACK, Model Number: DYNJ67504A; iii. SPECIALS TRACE PACK, Model Number: DYNJ57303A, DYNJ57303B; jjj. SSC GU ROBOTIC PACK, Model Number: DYNJ64027; kkk. ST CHARLES PORT PACK, Model Number: DYNJ49833J; lll. STERILE INJECTION PACK, Model Number: DYNDA2805; mmm. SUPPORT TRAY W/CHLORAPREP, Model Number: DYNJRA0958; nnn. SVMMC AV FISTULA PACK, Model Number: DYNJ48153C; ooo. SVMMC VASCULAR MAJOR PA

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: DYNJ54755B, UPC Number: 088994292536.   b. Model Number: DYNJ40306A, UPC Number: 088994260192.   c. Model Number: DYNJ0774759P, UPC Number: 019532724613.   d. Model Number: DYNJ902261D, UPC Number: 088994275524.   e. Model Number: DYNJRA1747, UPC Number: 019348946400.   f. Model Number: DYNJ44960D, UPC Number: 019348983324.   g. Model Number: DYNDV2285, UPC Number: 019348919454; Model Number: MNS9865, UPC Number: 065316029443.   h. Model Number: DYNJ904401B, UPC Number: 019348968343.   i. Model Number: DYNJ42262D, UPC Number: 088994269795.   j. Model Number: DYNJ47502B, UPC Number: 019348964922.   k. Model Number: DYNJ67414, UPC Number: 019348996464.   l. Model Number: PHS41739A, UPC Number: 088994290680.   m. Model Number: DYNJ60038, UPC Number: 088827779327.   n. Model Number: CDS982858F, UPC Number: 088827773921.   o. Model Number: DYNJ39885A, UPC Number: 088994253993.   p. Model Number: DYNJ41873B, UPC Number: 019348956306.   q. Model Number: DYNJ52688A, UPC Number: 088994284356.   r. Model Number: CDS982859F, UPC Number: 088827773920.   s. Model Number: DYNJ47717, UPC Number: 088827751458.   t. Model Number: DYNJ55723A, UPC Number: 088994286553; Model Number: DYNJ60990, UPC Number: 019348953847.   u. Model Number: DYNJ59067, UPC Number: 088994293004.   v. Model Number: DYNJ49177F, UPC Number: 088827777434.   w. Model Number: DYNDC2399A, UPC Number: 088994244693.   x. Model Number: DYNJ41114C, UPC Number: 019532726173.   y. Model Number: DYNJ54894A, UPC Number: 019348921355.   z. Model Number: DYNJ54894A, UPC Number: 019348921355.   aa. Model Number: DYNJ54982A, UPC Number: 019348980895.   bb. Model Number: CVI4765, UPC Number: 019348995318.   cc. Model Number: DYNJ56857B, UPC Number: 019348989314; Model Number: DYNJ68990, UPC Number: 019348987261.   dd. Model Number: DYNDA1468C, UPC Number: 088994284317; Model Number: DYNDA1468C, UPC Number: 10889942843176.   ee. Model Number: DYNJ64393, UPC Number: 019348980963.   ff. Model Number: DYNJRA1155B, UPC Number: 019348958371; Model Number: DYNJRA1200B, UPC Number: 019348956827.   gg. Model Number: DYNJRA1498, UPC Number: 019348979574.  hh. Model Number: DYNJ55063A, UPC Number: 019348968054; Model Number: DYNJ57674A, UPC Number: 088827777174; Model Number: DYNJ59795A, UPC Number: 019348956698; Model Number: DYNJ62588, UPC Number: 019348966983; Model Number: DYNJ64372, UPC Number: 019348980722; Model Number: DYNJ64372A, UPC Number: 019348988468; Model Number: DYNJ68968, UPC Number: 019348987039.    ii. Model Number: CDS984329J, UPC Number: 088994286535.   jj. Model Number: DYNJ62197, UPC Number: 019348963300.   kk. Model Number: DYNJ45757F, UPC Number: 088827779258.   ll. Model Number: DYNJ46549J, UPC Number: 019348933778.   mm. Model Number: DYNJ35574A, UPC Number: 088438953806; Model Number: DYNJ54131, UPC Number: 088994246680.   nn. Model Number: DYNJ60698B, UPC Number: 019532706789.   oo. Model Number: DYNJ63155A, UPC Number: 019348931402.   pp. Model Number: DYNJ42172A, UPC Number: 019348950271.   qq. Model Number: DYNJ58225B, UPC Number: 088827777898.   rr. Model Number: PHS479840M, UPC Number: 019348968272.   ss. Model Number: MNS11625, UPC Number: 065316032213.   tt. Model Number: DYNJ41114B, UPC Number: 088994269269.   uu. Model Number: DYNJRA1256, UPC Number: 019348951155.   vv. Model Number: DYNJ57149, UPC Number: 088994272160; Model Number: DYNJ67899, UPC Number: 019348945449.   ww. Model Number: DYNJ40379C, UPC Number: 088994281455.   xx. Model Number: DYNJ906112, UPC Number: 019348965663.   yy. Model Number: DYNJ60009A, UPC Number: 019348964887.   zz. Model Number: DYNJ905826B, UPC Number: 019348978095; Model Number: DYNJ905826C, UPC Number: 019348940758; Model Number: DYNJ905826D, UPC Number: 019532702352; Model Number: DYNJ905826F, UPC Number: 019532721705.   aaa. Model Number: DYNJ33546J, UPC Number: 019348956435.   bbb. Model Number: DYNJ0785821M, UPC Number: 019348956435; Model Number: DYNJ0785821N, UPC Number: 019348956435; Model Number: DYNJ0785821O, UPC Number: 019532726373.   ccc. Model Number: DYNJ62434A, UPC Number: 019348936627.   ddd. Model Number: DYNJ0369434M, UPC Number: 019532729542.   eee. Model Number: CDS984584L, UPC Number: 088994270130.   fff. Model Number: DYNJ53135B, UPC Number: 019348966082; Model Number: DYNJ53135C, UPC Number: 019348946843.   ggg. Model Number: DYNJ0416535U, UPC Number: 019348956435; Model Number: DYNJ0416535Y, UPC Number: 019348956435.   hhh. Model Number: DYNJ67504A, UPC Number: 019532700961.   iii. Model Number: DYNJ57303A, UPC Number: 088827778321; Model Number: DYNJ57303B, UPC Number: 019348936064.   jjj. Model Number: DYNJ64027, UPC Number: 019348977993.   kkk. Model Number: DYNJ49833J, UPC Number: 019532705946.   lll. Model Number: DYNDA2805, UPC Number: 019348984614.   mmm. Model Number: DYNJRA0958, UPC Number: 088994261890.   nnn. Model Number: DYNJ48153C, UPC Number: 088994276562.   ooo. Model Number: DYNJ43777G, UPC Number: 088994291573.   ppp. Model Number: DYNJ63339A, UPC Number: 019348929531; Model Number: DYNJ63339B, UPC Number: 019348984061.   qqq. Model Number: DYNJ53319C, UPC Number: 019348963449.   rrr. Model Number: DYNJ63340, UPC Number: 019348974116.   sss. Model Number: DYNJ906391B, UPC Number: 019348981688.   ttt. Model Number: DYNDH1190, UPC Number: 088994249424.   uuu. Model Number: DYKM2125, UPC Number: 019532704487.   vvv. Model Number: DYNJ58424, UPC Number: 088994285183.   www. Model Number: DYNJ37099C, UPC Number: 019348956435.   xxx. Model Number: DYNJ59062, UPC Number: 088994294165.   yyy. Model Number: TVS4300A, UPC Number: 081698202335.   zzz. Model Number: TVS4500A, UPC Number: 081698202337; Model Number: TVS4500B, UPC Number: 019532722356.   aaaa. Model Number: ULT2175B, UPC Number: 019348958303; Model Number: ULT2175C, UPC Number: 10653160344353.   bbbb. Model Number: DYNDV2537, UPC Number: 019532718408.   cccc. Model Number: DYNDC2099, UPC Number: 088827729567.   dddd. Model Number: DYNJ56535, UPC Number: 088994265334.   eeee. Model Number: DYNDH1319, UPC Number: 088994279547.   ffff. Model Number: DYNDV2385A, UPC Number: 019532729876.   gggg. Model Number: IVS3485A, UPC Number: 065316099015; Model Number: IVS3840A, UPC Number: 019348947673.   hhhh. Model Number: DYNDV2038B, UPC Number: 019348991983; Model Number: IVS3300, UPC Number: 065316030766; Model Number: IVS3495A, UPC Number: 065316099305.   iiii. Model Number: IVS3820, UPC Number: 065316034231.   jjjj. Model Number: DYNDV2371, UPC Number: 019348943086.   kkkk. Model Number: DYNJ56507B, UPC Number: 019348944347; Model Number: DYNJ64930, UPC Number: 019348923168.   llll. Model Number: DYNDH1112, UPC Number: 10889942277360.   mmmm. Model Number: IV8635D, UPC Number: 065316099026.   nnnn. Model Number: DYNDV2502, UPC Number: 019532701409.   oooo. Model Number: DYNDH1204, UPC Number: 088994251983; Model Number: DYNDH1468A, UPC Number: 019348944003; Model Number: DYNJRA0389, UPC Number: 088438972552; Model Number: DYNDH1204, UPC Number: 10889942519835.   pppp. Model Number: DYNJ61433, UPC Number: 019348956517.   qqqq. Model Number: DYNJ60006A, UPC Number: 019348981007.   rrrr. Model Number: DYNJ51638B, UPC Number: 019348994641; Model Number: DYNJ51638C, UPC Number: 019532703956.   ssss. Model Number: DYNDH1492, UPC Number: 019348943446.   tttt. Model Number: DYNJ904401B, UPC Number: 019348968343.   uuuu. Model Number: DYNJ902259A, UPC Number: 088994225654.   vvvv. Model Number: CDS982895I, UPC Number: 088994220768.   wwww. Model Number: DYNJ902261D, UPC Number: 088994275524.   xxxx. Model Number: DYNJ43593A, UPC Number: 088994225559; Model Number: DYNJ53475D, UPC Number: 019348954775.   yyyy. Model Number: VC-PK, UPC Number: 019532717689.   zzzz. Model Number: DYNJ63268B, UPC Number: 019348930511; Model Number: DYNJ66079, UPC Number: 019348931744.  aaaaa. Model Number: DYNJ61148A, UPC Number: 019348954925.   bbbbb. Model Number: DYNJ32397B, UPC Number: 088438991665; Model Number: DYNJ54139A, UPC Number: 088994256499; Model Number: DYNJ59094, UPC Number: 088994293350; Model Number: DYNJ65189C, UPC Number: 019532707200.   ccccc. Model Number: DYNJS3005, UPC Number: 088438909956.   ddddd. Model Number: DYNJ55841B, UPC Number: 088827775768.   eeeee. Model Number: DYNJ64190A, UPC Number: 019348943563.   fffff. Model Number: DYNJ0309084D, UPC Number: 088994288526; Model Number: DYNJ38682C, UPC Number: 088994289719; Model Number: DYNJ51248B, UPC Number: 088994287340; Model Number: DYNJ59662A, UPC Number: 019348954814; Model Number: DYNJ59681, UPC Number: 088827777552; Model Number: DYNJ61264, UPC Number: 019348955447.   ggggg. Model Number: DYNJ59631, UPC Number: 088827776402.   hhhhh. Model Number: DYNDA2076, UPC Number: 088994270850.   iiiii. Model Number: DYNJ38264C, UPC Number: 019348956435.   jjjjj. Model Number: DYNJ57736A, UPC Number: 088827777970.   kkkkk. Model Number: DYNJ59751A, UPC Number: 019348959856.   lllll. Model Number: DYNJ20094J, UPC Number: 019348956435; Model Number: DYNJ20094K, UPC Number: 019348956435.   mmmmm. Model Number: DYNJ56260B, UPC Number: 019348956982.   nnnnn. Model Number: DYNJ64666A, UPC Number: 019348931726.   ooooo. Model Number: DYNJ901392D, UPC Number: 019348953951.   ppppp. Model Number: DYNJ59246, UPC Number: 088827776729.   qqqqq. Model Number: DYNJ53349A, UPC Number: 088994257453.   rrrrr. Model Number: DYNJ35988G, UPC Number: 019348956435; Model Number: DYNJ35988I, UPC Number: 019348956435; Model Number: DYNJ35988J, UPC Number: 019532702466.   sssss. Model Number: DYNJ56392, UPC Number: 088994264067; Model Number: DYNJ56392A, UPC Number: 019532726140.

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-2321-2023
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-2321-2023 · Source: openFDA enforcement.