The Recall Desk
HighFDA (Devices)·Z-3045-2024·Announced 2024-09-18

Medline medical convenience kits recalled for defective plastic syringes

Medline is recalling medical convenience kits with plastic syringes affected by quality defects including leaks and breakage. The defective syringes 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: FDA Class II medical device recall involving quality defects (syringe leaks and breakage) in surgical procedure kits. The source reports no illnesses, injuries, or deaths; the risk is described as potential rather than confirmed. Per the rubric, when no incidents are reported and the hazard is theoretical, the maximum score is 3 (High).

Plain-English summary

Medline Industries, LP is recalling multiple medical convenience kits that contain plastic syringes with quality defects. The affected syringes are subject to an FDA Safety Alert issued on March 19, 2024.

The recalled kits include surgical and procedural packs used for pelviscopy, laparoscopy, dermatology, emergency care, and obstetric/gynecology procedures. The plastic syringes in these kits have experienced leaks, breakage, and other quality issues that may pose a risk to patient health.

The kits have been distributed worldwide to healthcare facilities and medical providers. Providers and facilities using any of the affected kit models or lot numbers should stop using them immediately and contact Medline Industries for instructions on replacement or return.

The recalled product

Product
Medline Convenience kits labeled as: 1) GROTH PELVISCOPY CDS, Pack Number CDS984187T ; 2) GROTH PELVISCOPY, Pack Number CDS984187U ; 3) DERMATOLOGY KIT, Pack Number DYNDA1567D; 4) ER MINOR SUTURE SET, Pack Number DYNDA1977A; 5) HSG TRAY, Pack Number DYNDH1453; 6) TRA
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Hazard
  • syringe-leak
  • syringe-breakage
  • product-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)

  • CDS984187T
  • Lot Number 22JBX647
  • Lot Number 22KBH092
  • Lot Number 22KBN639
  • Lot Number 23ABJ847
  • Lot Number 23DBN636
  • Lot Number 23EBN741
  • Lot Number 23FBO660
  • CDS984187U
  • Lot Number 23GBV733
  • Lot Number 23HBA604
  • Lot Number 23JBE143
  • Lot Number 23JBE436
  • Lot Number 23JBX523
  • Lot Number 23LBN764
  • Lot Number 24BBN238
  • Lot Number 24BBU609
  • DYNDA1567D
  • Lot Number 2019071090
  • DYNDA1977A

Distribution

Distribution scope not specified by the agency.