Medline Medical Convenience Kits with Defective Syringes Recalled
Medline Industries is recalling convenience kits containing plastic syringes with leaks, breakage, and quality defects identified by an FDA Safety Alert. These defects may pose risks to patient safety during medical procedures.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of medical devices used in invasive procedures where syringe defects could pose serious risk to patients. No illnesses or injuries have been reported in the source text. The defects are documented but their patient impact remains theoretical. Per the rubric, risk-of-harm products without reported injury score at most 3.
Plain-English summary
Medline Industries is recalling multiple medical convenience kits containing plastic syringes. The syringes were identified in an FDA Safety Alert issued on March 19, 2024, and exhibit leaks, breakage, and other quality defects that may pose a risk to patient health.
The affected kits are used in various medical procedures including angiography, catheterization, and other interventional procedures. The kits were distributed worldwide to healthcare facilities.
Healthcare facilities and patients using these kits should stop using them immediately. Affected users should contact Medline Industries regarding return and replacement of the recalled kits.
The recalled product
- Product
- Medline convenience kits labeled as: 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
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- leakage
- breakage
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 00-398281J
- Lot Number 19FBL693
- Lot Number 19HBQ768
- Lot Number 19IBJ984
- Lot Number 19JBM853
- 00-398650AG
- Lot Number 19ABM946
- Lot Number 19BBS748
- Lot Number 19CBJ825
- Lot Number 19DBR708
- Lot Number 19FBR243
- Lot Number 19IBV635
- Lot Number 19KBL462
- Lot Number 20MBA140
- Lot Number 20EBE408
- Lot Number 20FBJ771
- Lot Number 20HBI575
- Lot Number 20JBJ100
- Lot Number 21ABP363
- Lot Number 21ABQ027
Distribution
Distribution scope not specified by the agency.
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