The Recall Desk
HighFDA (Devices)·Z-2627-2024·Announced 2024-09-04

Medline Procedure Packs With Syringes Recalled for Quality Defects

Medline Industries has recalled over 1.6 million procedure packs containing syringes due to identified leaks, breakage, and quality issues that may pose a risk to patient health. The affected packs were distributed worldwide.

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: FDA Class II medical device recall for syringes with identified leaks and breakage. Although no illnesses or injuries have been reported, the defects pose a direct risk during medical procedures. This meets the High severity criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Medline Industries is recalling medical procedure packs containing plastic Shenli syringes used in angiography, catheterization, and other interventional procedures. Approximately 1,679,067 units have been affected by identified quality defects. These syringes are affected by an FDA Safety Alert issued March 19, 2024.

Identified issues include leaks, breakage, and other defects in the syringes. These quality issues may pose a risk to patient health during medical procedures.

The affected packs were distributed worldwide. Healthcare facilities should discontinue use of the recalled products and verify their inventory against the provided lot and pack numbers. Questions or concerns should be directed to Medline Industries or the FDA.

The recalled product

Product
Medline procedure packs containing Shenli syringes, labeled as follows: 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 ;
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Syringes and Injection Devices
Hazard
  • syringe-leaks
  • syringe-breakage
  • device-defect

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.

Related recalls

Same category