Reported Sep 4, 2024 · Ongoing

Medline procedure packs containing Shenli syringes, labeled as follows

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?

Medline procedure packs containing Shenli syringes, labeled as follows

5 of 5 products

Products covered by this recall
#Product as published
1DIALYSIS CATH ACCESS KIT, Pack Number DYNDA2516B
2DIALYSIS PACK , Pack Number DYNJ36932A
3DIALYSIS AV SHUNT #668229-V-LF, Pack Number DYNJ58502C
4DIALYSIS ACCESS PACK, Pack Number DYNJ910121
5NO CATH DIALYSIS INSERTN TRAY , Pack Number PICCNC0028
Lot codes and dates

12 of 12 products

Products covered by this recall
#Product as published
1DYNDA2516B , Lot Number 23IBE112
2DYNDA2516B , Lot Number 23JBH284
3DYNDA2516B , Lot Number 23KBE900
4DYNDA2516B , Lot Number 23LBO850
5DYNJ36932A , Lot Number 23FBK320
6DYNJ36932A , Lot Number 23GBU834
7DYNJ36932A , Lot Number 23HBG572
8DYNJ36932A , Lot Number 23LBL499
9DYNJ58502C , Lot Number 21IMD970
10DYNJ58502C , Lot Number 21KMA999
11DYNJ910121 , Lot Number 24CDB254
12PICCNC0028 , Lot Number 23KBL354
Amount recalled
1,679,067 units in total

This recall covers 55 products

The agency filed one notice per product. You are reading one of them; the other 54 are below.

42 more are in the archive.

Why it was recalled

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

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

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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, 6:58 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.