Class II FDA device recall · Z-2305-2023

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. A V FISTULA, Model Number: DYNJ65711; b. ACCESS CATHETER, Model Number: DYNJ64141A; c. ACCESS PICC PACK, Model Number: DYNJ40682B; d. ADULT EPIV INSERTION TRAY, Model Number: DYNDA2482; e. AFCH CVC INSERTION, Model Number: DYNJ67534; f. ANGIOGRAM-DECH-LF, Model Number: DYNJ81725; g. ART LINE KIT ICH OR, Model Number: ART900; h. ARTERIAL LINE PACK, Model Number: DYNJ49235D; i. ARTERIOGRAM PACK, Model Number: DYNJ53095A, DYNJ55169G; j. AV FISTULA, Model Number: DYNJ64143A, DYNJ905219A, DYNJ906341C, DYNJ906945; k. AV FISTULA PACK, Model Number: DYNJ52093I, DYNJ62733, DYNJ66916, DYNJ67178; l. AV FISTULA PACK-LF, Model Number: DYNJ48428C, DYNJ64499A, DYNJ69167; m. AV SHUNT PACK-LF, Model Number: DYNJ0781844W; n. BARIATRIC KIT, Model Number: DYNJ901145F; o. BASIC VEIN PACK, Model Number: DYNJ69426; p. BCH VEIN ABLATION, Model Number: DYNJ69796; q. CATH LAB-VEIN PROCEDURES, Model Number: DYNJ60329A; r. CENTRAL LINE BUNDLE PACK-LF, Model Number: DYNJ22338K; s. CENTRAL LINE INSERTION KIT, Model Number: DYNJ52894A; t. CENTRAL LINE INSERTION PACK, Model Number: CVI4805; u. CENTRAL LINE KIT, Model Number: DYNDC2582A; v. CENTRAL LINE KIT UTMB, Model Number: DYNDC3061; w. CENTRAL LINE PACK, Model Number: DYNJ30087C, DYNJ48096B; x. CENTRAL LINE PACK-LF, Model Number: DYNJ0220136Q; y. CENTRAL LINE PLACEMENT PACK-LF, Model Number: DYNJ32358G; z. CENTRAL LINE PROCEDURE KIT, Model Number: DT22260; aa. CENTRAL LINE TRAY, Model Number: CVI4705; bb. CENTRAL VENOUS ACCESS PACK-LF, Model Number: DYNJ0214541O; cc. CVC/PICC INSERTION PACK EH-LF, Model Number: DYNJ40204A, DYNJ40204B; dd. CVL PACK, Model Number: DYNJ00281O; ee. CVR ENDOVENOUS PACK, Model Number: DYNJ80643; ff. DBD-AV FISTULA, Model Number: DYNJ904398D; gg. DBD-CENTRAL LINE TRAY, Model Number: DYNJ42902C; hh. DBD-LEE VEIN PACK, Model Number: DYNJ54906C; ii. DBD-PICC LINE PACK-LF, Model Number: DYNJ0373077O; jj. DBD-VARICOSE VEIN PACK, Model Number: DYNJ82884, DYNJ82885; kk. DBD-VASCULAR PACK-LF, Model Number: DYNJ56968; ll. DBD-VASCULAR VEIN PACK, Model Number: DYNJ69769; mm. DBD-VEIN PACK, Model Number: DYNJ82033; nn. DBD-VENCLOSE PROCEDURE PACK, Model Number: DYNJ80123; oo. DBD-VENOUS ACCESS PORT INSERTION, Model Number: DYNJ902602I; pp. DBD-VENOUS PACK, Model Number: DYNJ44243C, DYNJ80692; qq. DECLOT ACCESS, Model Number: DYNJ907279A, DYNJ907279B; rr. DEXMED ACCESS PACK, Model Number: DYNJ83148; ss. ENDOVENOUS ABLATION PACK, Model Number: DYNJ53435D; tt. ENS PICC LINE-HEJ-LF, Model Number: DYNJ67606; uu. ENSEMBLE POWER PICC-HEJ-LF, Model Number: DYNJ65827; vv. ER CENTRAL LINE KIT, Model Number: P155508D; ww. FISTULA SAVANNAH PACK, Model Number: DYNJ69943; xx. FISTULAGRAM PACK-LF, Model Number: DYNJ63213; yy. FNA TRAY, Model Number: DYNDH1123B; zz. GENERAL AV FISTULA, Model Number: DYNJ906011B; aaa. GROTH LASER VEIN CDS, Model Number: CDS984193Q; bbb. I.R. PICC PACK, Model Number: DYNDA2759; ccc. IR CENTRAL VENOUS ACCESS, Model Number: DYNJ43267G; ddd. IR PICC TRAY, Model Number: DYNDH1223; eee. JVL-PACK PICC, Model Number: DYNJ66062; fff. KIT MAJOR VASCULAR, Model Number: DYNJ907262A; ggg. KIT VEIN ABLATION, Model Number: DYNJ907381; hhh. LASER VEIN EC PACK, Model Number: DYNJ82951; iii. MAX BARRIER ART LINE KIT, Model Number: ART950; jjj. MHC AV FISTULA, Model Number: DYNJ903705G; kkk. MID HUDSON PICC LINE PACK, Model Number: DYNJ53618A; lll. MIDLINE INSERTION KIT, Model Number: DYNJ45178; mmm. MSB BEDSIDE TRAY, Model Number: DYNJ54670; nnn. MV-IR-PICC PACK-LF, Model Number: DYNJ41554C; ooo. NENTRAL LINE TRAY, Model Number: DYNJ42902D; ppp. NEONATAL PICC LINE TRAY, Model Number: DYNDC2120B; qqq. OPEN VASCULA

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: DYNJ65711, UPC Number: 019348928509.   b. Model Number: DYNJ64141A, UPC Number: 019532727957.   c. Model Number: DYNJ40682B, UPC Number: 088994226721.   d. Model Number: DYNDA2482, UPC Number: 019348935160.   e. Model Number: DYNJ67534, UPC Number: 019348940932.   f. Model Number: DYNJ81725, UPC Number: 019532713675.   g. Model Number: ART900, UPC Number: 065316034254.   h. Model Number: DYNJ49235D, UPC Number: 019348989433.   i. Model Number: DYNJ53095A, UPC Number: 019532714872; Model Number: DYNJ55169G, UPC Number: 019348996756.   j. Model Number: DYNJ64143A, UPC Number: 019348928481; Model Number: DYNJ905219A, UPC Number: 019348928721; Model Number: DYNJ906341C, UPC Number: 019348981630; Model Number: DYNJ906945, UPC Number: 019348929927.   k. Model Number: DYNJ52093I, UPC Number: 019348933747; Model Number: DYNJ62733, UPC Number: 019348968502; Model Number: DYNJ66916, UPC Number: 019348938765; Model Number: DYNJ67178, UPC Number: 019348941674.   l. Model Number: DYNJ48428C, UPC Number: 019348970247; Model Number: DYNJ64499A, UPC Number: 019348986330; Model Number: DYNJ69167, UPC Number: 019348989918.   m. Model Number: DYNJ0781844W, UPC Number: 019348922653.   n. Model Number: DYNJ901145F, UPC Number: 019348932609.   o. Model Number: DYNJ69426, UPC Number: 019348993939.   p. Model Number: DYNJ69796, UPC Number: 019348997935.   q.  Model Number: DYNJ60329A, UPC Number: 019348997222.   r. Model Number: DYNJ22338K, UPC Number: 019348936830.   s. Model Number: DYNJ52894A, UPC Number: 088994243754.   t. Model Number: CVI4805, UPC Number: 019532706871.   u. Model Number: DYNDC2582A, UPC Number: 019348934939.   v. Model Number: DYNDC3061, UPC Number: 019348949581.   w. Model Number: DYNJ30087C, UPC Number: 088994275414; Model Number: DYNJ48096B, UPC Number: 088827793931.   x. Model Number: DYNJ0220136Q, UPC Number: 019348982348.   y. Model Number: DYNJ32358G, UPC Number: 088994252647.   z. Model Number: DT22260, UPC Number: 065316032919.   aa. Model Number: CVI4705, UPC Number: 019348983237.   bb. Model Number: DYNJ0214541O, UPC Number: 019532708888.   cc. Model Number: DYNJ40204A, UPC Number: 088994240964; Model Number: DYNJ40204B, UPC Number: 019532717845.   dd. Model Number: DYNJ00281O, UPC Number: 019348996296.   ee. Model Number: DYNJ80643, UPC Number: 019532705579.   ff. Model Number: DYNJ904398D, UPC Number: 019348970132.   gg. Model Number: DYNJ42902C, UPC Number: 019532708468.   hh. Model Number: DYNJ54906C, UPC Number: 019532718876.    ii. Model Number: DYNJ0373077O, UPC Number: 088994236495.   jj. Model Number: DYNJ82884, UPC Number: 019532721599; Model Number: DYNJ82885, UPC Number: 019532721600.   kk. Model Number: DYNJ56968, UPC Number: 088994269923.   ll. Model Number: DYNJ69769, UPC Number: 019348997779.   mm. Model Number: DYNJ82033, UPC Number: 019532716297.   nn. Model Number: DYNJ80123, UPC Number: 019532700918.   oo. Model Number: DYNJ902602I, UPC Number: 019348989256.   pp. Model Number: DYNJ44243C, UPC Number: 019348970140; Model Number: DYNJ80692, UPC Number: 019532706554.   qq. Model Number: DYNJ907279A, UPC Number: 019348990771; Model Number: DYNJ907279B, UPC Number: 019532711639.   rr. Model Number: DYNJ83148, UPC Number: 019532723551.   ss. Model Number: DYNJ53435D, UPC Number: 019532719644.   tt. Model Number: DYNJ67606, UPC Number: 019348942167.   uu. Model Number: DYNJ65827, UPC Number: 019348929849.   vv. Model Number: P155508D, UPC Number: 019348989906.   ww. Model Number: DYNJ69943, UPC Number: 019348999844.   xx. Model Number: DYNJ63213, UPC Number: 019348972821.   yy. Model Number: DYNDH1123B, UPC Number: 019348946555.   zz. Model Number: DYNJ906011B, UPC Number: 019348941123.   aaa. Model Number: CDS984193Q, UPC Number: 019532725508.   bbb. Model Number: DYNDA2759, UPC Number: 019348948819.   ccc. Model Number: DYNJ43267G, UPC Number: 019532728880.   ddd. Model Number: DYNDH1223, UPC Number: 10889942567539.   eee. Model Number: DYNJ66062, UPC Number: 019348931921.   fff. Model Number: DYNJ907262A, UPC Number: 019348990913.   ggg. Model Number: DYNJ907381, UPC Number: 019348990077.   hhh. Model Number: DYNJ82951, UPC Number: 019532721897.   iii. Model Number: ART950, UPC Number: 065316033022.   jjj. Model Number: DYNJ903705G, UPC Number: 019348934550.   kkk. Model Number: DYNJ53618A, UPC Number: 088994249249.   lll. Model Number: DYNJ45178, UPC Number: 088827709574.   mmm. Model Number: DYNJ54670, UPC Number: 088994249957.   nnn. Model Number: DYNJ41554C, UPC Number: 088994281132.   ooo. Model Number: DYNJ42902D, UPC Number: 019532717110.   ppp. Model Number: DYNDC2120B, UPC Number: 019348936335.   qqq. Model Number: DYNJ907858, UPC Number: 019348990935.   rrr. Model Number: DYNJ81592, UPC Number: 019532712377.   sss. Model Number: DYNJ81669, UPC Number: 019532713232; Model Number: DYNJ81669B, UPC Number: 019532725343.   ttt. Model Number: CVI3650, UPC Number: 065316025639.   uuu. Model Number: MNS13555, UPC Number: 065316099195.   vvv. Model Number: DYNJ40990C, UPC Number: 088994202437.   www. Model Number: DYNJ39039M, UPC Number: 019348989850.   xxx. Model Number: GSS584Q, UPC Number: 019348994102.   yyy. Model Number: CVI3830, UPC Number: 065316026994; Model Number: CVI4025A, UPC Number: 019348939605.   zzz. Model Number: DYNJ60038A, UPC Number: 019532703833; Model Number: DYNJ61637, UPC Number: 019348958546.   aaaa. Model Number: DYNJ40206A, UPC Number: 088827702610; Model Number: DYNJ40206B, UPC Number: 019532717644.   bbbb. Model Number: DYNJ67415, UPC Number: 019348993088.   cccc. Model Number: DYNJ51852B, UPC Number: 088994248122.   dddd. Model Number: DYNJ70141MB, UPC Number: 088994272280.   eeee. Model Number: DYNJ70152MB, UPC Number: 088994272282.   ffff. Model Number: DYNJ55546C, UPC Number: 019348927672; Model Number: DYNJ55546D, UPC Number: 019532705652; Model Number: DYNJ64337, UPC Number: 019348980028.   gggg. Model Number: DYNJ38868K, UPC Number: 019348956435; Model Number: DYNJ38868L, UPC Number: 019532722477.   hhhh. Model Number: DYNJ34241, UPC Number: 088438933586.   iiii. Model Number: DYNJ04592K, UPC Number: 019348921520; Model Number: DYNJ17017F, UPC Number: 019348956435; Model Number: DYNJ30233C, UPC Number: 019348938257; Model Number: DYNJ44089A, UPC Number: 088994249268; Model Number: DYNJ47037C, UPC Number: 019348961600; Model Number: DYNJ55170, UPC Number: 088994253218; Model Number: DYNJ55170A, UPC Number: 019348990860; Model Number: DYNJ55170B, UPC Number: 019348996757; Model Number: DYNJ55170C, UPC Number: 019532713535; Model Number: DYNJ64249A, UPC Number: 019348938136; Model Number: DYNJ65903, UPC Number: 019348930065.   jjjj. Model Number: DYNJ0235859I, UPC Number: 019348956435; Model Number: DYNJ0235859J, UPC Number: 019532706927; Model Number: DYNJ0235859K, UPC Number: 019532724321; Model Number: DYNJ0678523M, UPC Number: 019348956435; Model Number: DYNJ0678523N, UPC Number: 019348999404; Model Number: DYNJ0855123N, UPC Number: 019532709488; Model Number: DYNJ21575G, UPC Number: 019348956435; Model Number: DYNJ21575I, UPC Number: 019532700967.   kkkk. Model Number: DYNJ52688B, UPC Number: 019348945247; Model Number: DYNJ52688C, UPC Number: 019532730102; Model Number: DYNJ64725B, UPC Number: 019348945284.   llll. Model Number: DYNJT2272J, UPC Number: 019348926312; Model Number: DYNJT2272K, UPC Number: 019532725067.   mmmm. Model Number: DYNJ47717B, UPC Number: 019532735530.   nnnn. Model Number: DYNJ35323, UPC Number: 019348956435.   oooo. Model Number: DYNJ30566B, UPC Number: 088994237552; Model Number: DYNJ52255, UPC Number: 088994225370; Model Number: DYNJ60990A, UPC Number: 019348948445; Model Number: DYNJ60990B, UPC Number: 019348992170;  Model Number: DYNJ65838, UPC Number: 019348930326; Model Number: DYNJ69088, UPC Number: 019348988361; Model Number: DYNJ69088A, UPC Number: 019348997524.   pppp. Model Number: DYNJ0940720D, UPC Number: 088994255095; Model Number: DYNJ17086A, UPC Number: 088438906430; Model Number: DYNJ35000I, UPC Number: 019348926164; Model Number: DYNJ48120B, UPC Number: 088827789487; Model Number: DYNJ63162, UPC Number: 019348972089.   qqqq. Model Number: DYNDC2373A, UPC Number: 088994249220.   rrrr. Model Number: DYNJ33005D, UPC Number: 019348956435; Model Number: DYNJ33005F, UPC Number: 019348956435; Model Number: DYNJ35272, UPC Number: 088438942826; Model Number: DYNJ41648, UPC Number: 088438990917; Model Number: PICCNC0008, UPC Number: 019532722158.   ssss. Model Number: DYNJ63590, UPC Number: 019348976918.   tttt. Model Number: DYNJ31725A, UPC Number: 019348956435.   uuuu. Model Number: DYNJ81726, UPC Number: 019532713677.   vvvv. Model Number: DYNJ81284, UPC Number: 019532710571.   wwww. Model Number: DYNJ35163C, UPC Number: 088994249468; Model Number: DYNJ56857A, UPC Number: 088994274727; Model Number: DYNJ56857C, UPC Number: 019348996758.   xxxx. Model Number: DYNJ65775, UPC Number: 019348928982.   yyyy. Model Number: DYNJ83534, UPC Number: 019532727671.   zzzz. Model Number: DYNJ61894B, UPC Number: 019532700387.

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-2305-2023
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-2305-2023 · Source: openFDA enforcement.