Reported Aug 9, 2023 · Ongoing

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following

MEDLINE INDUSTRIES, LP - Northfield

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: MEDLINE INDUSTRIES, LP - Northfield · 3 Lakes Dr · Northfield, IL · 60093-2753

Is this the product you have?

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following

26 of 26 products

Products covered by this recall
Model / numberProduct as published
DYNJ902507BANGIO
ANGIO BASIN SET, Model Numbers: DYNJ46043D, DYNJ46043F
ANGIO CATH COMBINED PACK, Model Numbers: DYNJ43609K, DYNJ43609L, DYNJ43609M, DYNJ43609N
DYNJ17624BANGIO DRAPE PACK, , DYNJ44320F
DYNJ47951AANGIO DRAPE SPEC PROC PACK
DYNJ40632CANGIO LEFT HEART PACK
ANGIO PACK, Model Numbers: DYNJ30141, DYNJ34361, DYNJ42903B, DYNJ43661B, DYNJ47226A, DYNJ50624A, DYNJ51239A, DYNJ58111C, DYNJ58126A, DYNJ62299, DYNJ62544, DYNJ65043A, DYNJ66398A, DYNJ66398B
DYNJ60507AANGIO PACK 2-A
ANGIO PACK-LF, Model Numbers: DYNJ0373279L, DYNJ0373279M
ANGIO TRAY, Model Numbers: DYNJ46153A, DYNJ46153B, DYNJ52121
DYNJ62742ANGIO TRAY W/CHLORAPREP
DYNJ36049ANGIO/PICC PACK
DYNJ0149444MANGIOGRAM
ANGIOGRAM PACK, Model Numbers: DYNJ45007, DYNJ47004C, DYNJ66244
DYNJ33638KANGIOGRAM TRAY
ANGIOGRAPHY DRAPE PACK, Model Numbers: DYNJ49621B, DYNJ63060A, DYNJ63684F, DYNJ68065, DYNJ68065A, DYNJT2344B
ANGIOGRAPHY DRAPE PACK-LF, Model Numbers: DYNJ28067G, DYNJVB1135A
ANGIOGRAPHY DRP PK PEDI CATH, Model Numbers: 00-401318L, 00-401318M
CDS984944CANGIOGRAPHY OR
ANGIOGRAPHY PACK, Model Numbers: DYNJ44293D, DYNJ47906, DYNJ55252B, DYNJ57498, DYNJ65190C, DYNJ66476, DYNJC2371G
Lot codes and dates

26 of 26 products

Products covered by this recall
Model / numberBarcodesProduct as published
DYNJ902507B088994278118UPC Number: 088994278118.
DYNJ46043F019348935036019348985672Model Number: DYNJ46043D, UPC Number: 019348935036; , UPC Number: 019348985672.
DYNJ43609N019348950140019348960178019348962744019348928212Model Number: DYNJ43609K, UPC Number: 019348950140; Model Number: DYNJ43609L, UPC Number 019348960178; Model Number: DYNJ43609M, UPC Number 019348962744; , UPC Number 019348928212.
DYNJ44320F019348986729019348943551Model Number: DYNJ17624B, UPC Number: 019348986729; , UPC Number 019348943551.
DYNJ47951A019348960984UPC Number: 019348960984.
DYNJ40632C019348946117UPC Number: 019348946117.
DYNJ66398B019348956435088438934847088827779801088994280870088827756181088994247463088994249354019348984600019348948475019348964151019348966652019348937932019348941416019348989192Model 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; , UPC Number 019348989192.
DYNJ60507A019348983055UPC Number: 019348983055.
DYNJ0373279M019348956435019348951902Model Number: DYNJ0373279L, UPC Number: 019348956435; , UPC Number: 019348951902.
DYNJ52121088994218586019348985364088994224362Model Number: DYNJ46153A, UPC Number: 088994218586; Model Number: DYNJ46153B, UPC Number: 019348985364; , UPC Number: 088994224362.
DYNJ62742019348968592UPC Number: 019348968592, Lot Numbers: 21LBP049, 22OBH570, 22EBP081, 22FBG069, 20XBB252, 21BBH070, 21DBJ756.
DYNJ36049019348956435UPC Number: 019348956435.
DYNJ0149444M019348956435UPC Number: 019348956435.
DYNJ66244088827708541019348969617019348932371Model Number: DYNJ45007, UPC Number: 088827708541; Model Number: DYNJ47004C, UPC Number: 019348969617; , UPC Number: 019348932371.
DYNJ33638K019348934328UPC Number: 019348934328.
DYNJT2344B088994228223019348942308019348989720019348947511019348988872088994210780Model 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; , UPC Number: 088994210780.
DYNJVB1135A088994274429019348933993Model Number: DYNJ28067G, UPC Number: 088994274429; , UPC Number: 019348933993.
00-401318M088827709176019348934875Model Number: 00-401318L, UPC Number: 088827709176; , UPC Number: 019348934875.
CDS984944C088994217295UPC Number: 088994217295.
DYNJC2371G019348983341088827752837019348987015088994274574019348943311019348935677088994249467Model 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; , UPC Number: 088994249467.
Amount recalled
63,823 kits

This recall covers 50 products

The agency filed one notice per product. You are reading one of them; the other 49 are below.

37 more are in the archive.

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 4:52 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.