Class II FDA device recall · Z-2296-2023

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. ANGIO, Model Number: DYNJ902507B; b. ANGIO BASIN SET, Model Numbers: DYNJ46043D, DYNJ46043F; c. ANGIO CATH COMBINED PACK, Model Numbers: DYNJ43609K, DYNJ43609L, DYNJ43609M, DYNJ43609N; d. ANGIO DRAPE PACK, Model Number: DYNJ17624B, DYNJ44320F; e. ANGIO DRAPE SPEC PROC PACK, Model Number: DYNJ47951A; f. ANGIO LEFT HEART PACK, Model Number: DYNJ40632C; g. ANGIO PACK, Model Numbers: DYNJ30141, DYNJ34361, DYNJ42903B, DYNJ43661B, DYNJ47226A, DYNJ50624A, DYNJ51239A, DYNJ58111C, DYNJ58126A, DYNJ62299, DYNJ62544, DYNJ65043A, DYNJ66398A, DYNJ66398B; h. ANGIO PACK 2-A, Model Number: DYNJ60507A; i. ANGIO PACK-LF, Model Numbers: DYNJ0373279L, DYNJ0373279M; j. ANGIO TRAY, Model Numbers: DYNJ46153A, DYNJ46153B, DYNJ52121; k. ANGIO TRAY W/CHLORAPREP, Model Number: DYNJ62742; l. ANGIO/PICC PACK, Model Number: DYNJ36049; m. ANGIOGRAM, Model Number: DYNJ0149444M; n. ANGIOGRAM PACK, Model Numbers: DYNJ45007, DYNJ47004C, DYNJ66244; o. ANGIOGRAM TRAY, Model Number: DYNJ33638K; p. ANGIOGRAPHY DRAPE PACK, Model Numbers: DYNJ49621B, DYNJ63060A, DYNJ63684F, DYNJ68065, DYNJ68065A, DYNJT2344B; q. ANGIOGRAPHY DRAPE PACK-LF, Model Numbers: DYNJ28067G, DYNJVB1135A; r. ANGIOGRAPHY DRP PK PEDI CATH, Model Numbers: 00-401318L, 00-401318M; s. ANGIOGRAPHY OR, Model Number: CDS984944C; t. ANGIOGRAPHY PACK, Model Numbers: DYNJ44293D, DYNJ47906, DYNJ55252B, DYNJ57498, DYNJ65190C, DYNJ66476, DYNJC2371G; u. ANGIOGRAPHY PACK-LF, Model Number: DYNJ0854485T; v. ANGIOPLASTY PACK-LF, Model Numbers: DYNJ43203F, DYNJ64655A; w. CATH LAB PACK, Model Number: DYNJ65185; x. CLOVIS CATH LAB PACK, Model Number: DYNJ62379; y. CUSTOM ANGIO TRAY, Model Number: DYNJ41649F; z. CVOR ANGIOGRAPHY PACK-LF, Model Number: DYNJ42367A; aa. DASHTI-YAO NEURO ANGIO-LF, Model Number: DYNJ33457C; bb. DBD-ANGIO TRAY, Model Number: DYNJ68758; cc. DBD-CATH PACK, Model Number: DYNJ63527; dd. DBD-CLOVIS CATH LAB PACK, Model Number: DYNJ62379; ee. DEPAUL ANGIO PACK, Model Number: DYNJ19939M; ff. EH VASCULAR ANGIO, Model Number: DYNJ49931F; gg. ENDOVASCULAR KIT, Model Number: DYNJ906354C; hh. EP ANGIOGRAPHY PACK, Model Number: DYNJ24225K; ii. FEMORAL ANGIOGRAPY SET UP, Model Number: DYNJ61015B; jj. FS ANGIO, Model Number: DYNJ42499C; kk. GENERAL ANGIO PACK, Model Number: DYNJ57760B; ll. HH ANGIO PACK, Model Number: DYNJ59465B; mm. IPMC ANGIOGRAPHY PACK-LF, Model Number: DYNJ0806254D; nn. IR MINOR ANGIO PACK, Model Number: DYNJ37665B; oo. KENNESTONE ANGIO, Model Number: WK100B; pp. MH HOOD CARDIAC ANGIO, Model Numbers: DYNJ49884B, DYNJ49884F; qq. MV-IR ANGIO DRAPE PACK-LF, Model Number: DYNJ41553D; rr. OR ANGIO PACK, Model Number: DYNJ60319A; ss. OR ANGIOGRAPHY PACK, Model Number: DYNJ67245; tt. PACK,BASIC ANGIO, Model Number: DYNJ65482A; uu. PEDI ANGIO PACK-LF, Model Number: PHS41743D; vv. PEDIATRIC CATH ANGIO PACK, Model Numbers: DYNJ54755D, DYNJ54755F; ww. PERCUTANEOUS ANGIO CHRG, Model Number: DYNJ60112; xx. PERCUTANEOUS ANGIO PACK-LF, Model Numbers: DYNJ57645A, DYNJ57645B; yy. PORT PACK, Model Number: DYNJ61747A; zz. SUNSHINE PACK, Model Number: DYNJ64830; aaa. SURGERY ANGIO PACK-LF, Model Number: DYNJ66500; bbb. VASCULAR ANGIO PACK-LF, Model Numbers: DYNJ0201109AG

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: DYNJ902507B, UPC Number: 088994278118.  b. Model Number: DYNJ46043D, UPC Number: 019348935036; Model Number: DYNJ46043F, UPC Number: 019348985672.   c. Model Number: DYNJ43609K, UPC Number: 019348950140; Model Number: DYNJ43609L, UPC Number 019348960178; Model Number: DYNJ43609M, UPC Number 019348962744; Model Number: DYNJ43609N, UPC Number 019348928212.  d. Model Number: DYNJ17624B, UPC Number: 019348986729; Model Number: DYNJ44320F, UPC Number 019348943551.  e. Model Number: DYNJ47951A, UPC Number: 019348960984.  f. Model Number: DYNJ40632C, UPC Number: 019348946117.  g. Model Number: DYNJ30141, UPC Number: 019348956435; Model Number: DYNJ34361, UPC Number 088438934847; Model Number: DYNJ42903B, UPC Number: 088827779801; Model Number: DYNJ43661B, UPC Number 088994280870; Model Number: DYNJ47226A, UPC Number: 088827756181; Model Number: DYNJ50624A, UPC Number 088994247463; Model Number: DYNJ51239A, UPC Number: 088994249354; Model Number: DYNJ58111C, UPC Number 019348984600; Model Number: DYNJ58126A, UPC Number: 019348948475; Model Number: DYNJ62299, UPC Number 019348964151; Model Number: DYNJ62544, UPC Number: 019348966652; Model Number: DYNJ65043A, UPC Number 019348937932; Model Number: DYNJ66398A, UPC Number: 019348941416; Model Number: DYNJ66398B, UPC Number 019348989192.   h. Model Number: DYNJ60507A, UPC Number: 019348983055.   i. Model Number: DYNJ0373279L, UPC Number: 019348956435; Model Number: DYNJ0373279M, UPC Number: 019348951902.  j. Model Number: DYNJ46153A, UPC Number: 088994218586; Model Number: DYNJ46153B, UPC Number: 019348985364; Model Number: DYNJ52121, UPC Number: 088994224362.  k. Model Number: DYNJ62742, UPC Number: 019348968592, Lot Numbers: 21LBP049, 22OBH570, 22EBP081, 22FBG069, 20XBB252, 21BBH070, 21DBJ756.  l. Model Number: DYNJ36049, UPC Number: 019348956435.   m. Model Number: DYNJ0149444M, UPC Number: 019348956435.   n. Model Number: DYNJ45007, UPC Number: 088827708541; Model Number: DYNJ47004C, UPC Number: 019348969617; Model Number: DYNJ66244, UPC Number: 019348932371.    o. Model Number: DYNJ33638K, UPC Number: 019348934328.  p. Model Number: DYNJ49621B, UPC Number: 088994228223; Model Number: DYNJ63060A, UPC Number: 019348942308; Model Number: DYNJ63684F, UPC Number: 019348989720; Model Number: DYNJ68065, UPC Number: 019348947511; Model Number: DYNJ68065A, UPC Number: 019348988872; Model Number: DYNJT2344B, UPC Number: 088994210780.  q. Model Number: DYNJ28067G, UPC Number: 088994274429; Model Number: DYNJVB1135A, UPC Number: 019348933993.  r. Model Number: 00-401318L, UPC Number: 088827709176; Model Number: 00-401318M, UPC Number: 019348934875.  s. Model Number: CDS984944C, UPC Number: 088994217295.  t. Model Number: DYNJ44293D, UPC Number: 019348983341; Model Number: DYNJ47906, UPC Number: 088827752837; Model Number: DYNJ55252B, UPC Number: 019348987015; Model Number: DYNJ57498, UPC Number: 088994274574; Model Number: DYNJ65190C, UPC Number: 019348943311; Model Number: DYNJ66476, UPC Number: 019348935677; Model Number: DYNJC2371G, UPC Number: 088994249467.  u. Model Number: DYNJ0854485T, UPC Number: 019348986419.  v. Model Number: DYNJ43203F, UPC Number: 019348939286; Model Number: DYNJ64655A, UPC Number: 019348986331.  w.  Model Number: DYNJ65185, UPC Number: 019348925314.  x. Model Number: DYNJ62379, UPC Number: 019348965170.  y. Model Number: DYNJ41649F, UPC Number: 019348964127.  z. Model Number: DYNJ42367A, UPC Number: 088827794377.   aa. Model Number: DYNJ33457C, UPC Number: 019348946180.   bb.  Model Number: DYNJ68758, UPC Number: 019348983756.   cc. Model Number: DYNJ63527, UPC Number: 019348974839.   dd. Model Number: DYNJ62379, UPC Number: 019348965170.   ee. Model Number: DYNJ19939M, UPC Number: 019348939324.   ff. Model Number: DYNJ49931F, UPC Number: 019348947166.   gg. Model Number: DYNJ906354C, UPC Number: 019348981670.   hh. Model Number: DYNJ24225K, UPC Number: 088994251070.   ii. Model Number: DYNJ61015B, UPC Number: 019348936888.   jj. Model Number: DYNJ42499C, UPC Number: 019532703086.   kk. Model Number: DYNJ57760B, UPC Number: 019348934258.   ll. Model Number: DYNJ59465B, UPC Number: 019348947093.   mm. Model Number: DYNJ0806254D, UPC Number: 088994247116.   nn. Model Number: DYNJ37665B, UPC Number: 088994296973.   oo. Model Number: WK100B, UPC Number: 019348934875.   pp. Model Number: DYNJ49884B, UPC Number: 088994236366; Model Number: DYNJ49884F, UPC Number: 019348946957.   qq. Model Number: DYNJ41553D, UPC Number: 088994281133.   rr. Model Number: DYNJ60319A, UPC Number: 019348927629.   ss. Model Number: DYNJ67245, UPC Number: 019348939305.   tt. Model Number: DYNJ65482A, UPC Number: 019348941682.   uu. Model Number: PHS41743D, UPC Number: 019348945327.   vv. Model Number: DYNJ54755D, UPC Number: 019348943426; Model Number: DYNJ54755F, UPC Number: 019348988460.   ww. Model Number: DYNJ60112, UPC Number: 088827779984.   xx. Model Number: DYNJ57645A, UPC Number: 019348955794; Model Number: DYNJ57645B, UPC Number: 019348982865.   yy. Model Number: DYNJ61747A, UPC Number: 019348971965.   zz. Model Number: DYNJ64830, UPC Number: 019348922313.   aaa. Model Number: DYNJ66500, UPC Number: 019348935791.   bbb. Model Number: DYNJ0201109AG, UPC Number: 019348949726.

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-2296-2023
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-2296-2023 · Source: openFDA enforcement.