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
75 of 75 products
| # | Product as published |
|---|---|
| 1 | ANGIOGRAPHY DRAPE PACK, Pack Number 00-398281J |
| 2 | ANGIOGRAPHY DRAPE PACK, Pack Number 00-398650AG |
| 3 | ANGIOGRAPHY DRAPE PACK, Pack Number 00-398650AI |
| 4 | ANGIOGRAPHY DRAPE PK, Pack Number 00-398712S |
| 5 | CATH LAB PACK , Pack Number 00-398725AM |
| 6 | ANGIOGRAPHY DRAPE PACK, Pack Number 00-399360K |
| 7 | ANGIOGRAPHY DRAPE PACK, Pack Number 00-399734N |
| 8 | ANGIOGRAPHY DRAPE PACK, Pack Number 00-399983Q |
| 9 | ANGIOGRAPHY DRAPE PACK, Pack Number 00-399983R |
| 10 | ANGIOGRAPHY DRAPE PACK, Pack Number 00-400065K |
| 11 | ANGIO PROCEDURE PACK, Pack Number 00-400069F |
| 12 | ANGIOGRAPHY DRAPE PACK PTCA , Pack Number 00-400123AC |
| 13 | ANGIOGRAPHY DRAPE PACK PTCA , Pack Number 00-400123AD |
| 14 | ANGIO PROCEDURE PACK, Pack Number 00-400290D |
| 15 | ANGIOGRAPHY DRAPE PACK, Pack Number 00-400305Q |
| 16 | MOUNT SINAI HOSPITAL-ANGIO PK , Pack Number 00-400763F |
| 17 | ANGIOGRAPHY DRAPE PACK-LF , Pack Number 00-400863J |
| 18 | ANGIOGRAPHY DRAPE , Pack Number 00-400932O |
| 19 | ANGIOGRAPHY DRAPE PACK, Pack Number 00-401030S |
| 20 | ANGIOGRAPHY DRAPE PACK, Pack Number 00-401178D |
- Lot codes and dates
895 of 895 products
Products covered by this recall # Product as published 1 Lot Number 19FBL693 ; 00-398281J 2 Lot Number 19HBQ768 ; 00-398281J 3 Lot Number 19IBJ984 ; 00-398281J 4 Lot Number 19JBM853 ; 00-398650AG 5 Lot Number 19ABM946 ; 00-398650AG 6 Lot Number 19BBS748 ; 00-398650AG 7 Lot Number 19CBJ825 ; 00-398650AG 8 Lot Number 19DBR708 ; 00-398650AG 9 Lot Number 19FBR243 ; 00-398650AG 10 Lot Number 19IBV635 ; 00-398650AG 11 Lot Number 19KBL462 ; 00-398650AG 12 Lot Number 20MBA140 ; 00-398650AG 13 Lot Number 20EBE408 ; 00-398650AG 14 Lot Number 20FBJ771 ; 00-398650AG 15 Lot Number 20HBI575 ; 00-398650AG 16 Lot Number 20JBJ100 ; 00-398650AG 17 Lot Number 21ABP363 ; 00-398650AG 18 Lot Number 21ABQ027 ; 00-398650AI 19 Lot Number 21FBT441 ; 00-398650AI 20 Lot Number 21IBH355 ; 00-398650AI - 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.
Want the full recall guide?
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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