The Recall Desk
HighFDA (Devices)·Z-2998-2024·Announced 2024-09-18

Medline surgical convenience kits recalled due to defective plastic syringes

Medline is recalling multiple surgical and medical convenience kits containing plastic syringes affected by a safety alert. Leaks, breakage, and quality issues may affect 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 FDA Class II recall involves medical devices used in surgical procedures. Although no illnesses or injuries have been reported, the identified defects in plastic syringes—including leaks and breakage—pose a genuine risk of harm during medical procedures.

Plain-English summary

Medline Industries is recalling multiple surgical and medical convenience kits that contain plastic syringes affected by an FDA Safety Alert issued on March 19, 2024. The affected kits are used for various medical procedures including biopsies, arterial line placement, circumcision, colonoscopy, and other interventional procedures.

The recalled plastic syringes have been identified with quality defects including leaks, breakage, and other issues that may pose a risk to patient health. These defects could impact the integrity of the syringes during medical procedures.

The recall affects multiple convenience kit products distributed worldwide with various pack numbers and lot numbers dating from 2018 to 2024. Healthcare facilities and practitioners who have received these kits should identify affected products using the provided pack and lot numbers and contact Medline Industries for instructions on return or replacement.

The recalled product

Product
Medline Convenience kits labeled as: 1) BIOPSY PROCEDURE PACK, Pack Number 00-400162J; 2) BIOPSY PROCEDURE TRAY , Pack Number 00-400405C ; 3) BIOPSY DRAPE PACK , Pack Number 00-400762H ; 4) BIOPSY PROCEDURE PACK , Pack Number 00-400832N ; 5) BIOPSY PROCEDURE PACK , Pack Num
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical Kits / Procedure Packs
Hazard
  • syringe-defect
  • 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)

  • 00-400162J
  • Lot Number 24BMJ154
  • Lot Number 21HBM269
  • Lot Number 21IBK734
  • Lot Number 21VBB786
  • Lot Number 21KBS936
  • Lot Number 21LBA763
  • Lot Number 22ABN222
  • Lot Number 19ABM483
  • Lot Number 19BBI451
  • Lot Number 19CBM173
  • Lot Number 19DBL959
  • Lot Number 22FBO944
  • Lot Number 19FBG533
  • Lot Number 22JBB402
  • Lot Number 19TBB201
  • Lot Number 22KBV632
  • Lot Number 19JBD745
  • Lot Number 19KBI828
  • Lot Number 19LBK452

Distribution

Distribution scope not specified by the agency.

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