The Recall Desk
HighFDA (Devices)·Z-3037-2024·Announced 2024-09-18

Medline Medical Convenience Kits with Plastic Syringes Recalled for Leaks and Breakage

Medline Industries is recalling medical convenience kits containing plastic syringes due to leaks, breakage, and quality issues that may pose patient safety risks. The recall affects multiple pack types 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: This is an FDA Class II recall affecting medical devices used in high-risk surgical and interventional procedures. While no illnesses or injuries are reported in the source, syringe leaks and breakage pose legitimate patient safety risks in these settings, qualifying this as High severity per the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Medline Industries, LP is recalling multiple medical convenience kits that contain plastic syringes affected by an FDA Safety Alert. The recalled kits include EP Drape packs, Mercy Combined packs, Pacemaker Drape packs, Femoral Angiography packs, and various other procedural convenience kits. The kits are distributed worldwide and include multiple lot numbers.

The plastic syringes in these convenience kits are subject to an FDA Safety Alert issued on March 19, 2024. Quality issues including leaks, breakage, and other defects have been identified with these syringes. These issues may pose a risk to patient health and safety, particularly in surgical and interventional procedures where the kits are used.

Healthcare facilities and hospitals should immediately stop using affected lots and contact Medline Industries for return or replacement instructions. The specific affected pack numbers and lot numbers are listed in the FDA recall notice. Patients who underwent procedures using these kits should consult their healthcare provider if they have concerns.

The recalled product

Product
Medline Convenience kits labeled as: 1) EP DRAPE PACK-LF, Pack Number DYNJ0209716K ; 2) MERCY COMBINED PACK-LF, Pack Number DYNJ0233004D ; 3) E P DRAPE PACK-LF , Pack Number DYNJ0373061J ; 4) PACEMAKER DRAPE PACK-LF , Pack Number DYNJ0406118K ; 5) FEMORAL ANGIOGRAPHY P
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical Convenience Kits
Hazard

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)

  • DYNJ0209716K
  • Lot Number 19ABR348
  • Lot Number 19CBC954
  • Lot Number 19CBY010
  • Lot Number 19PBC426
  • DYNJ0233004D
  • Lot Number 19BKC696
  • Lot Number 19EKB353
  • Lot Number 19EKD788
  • Lot Number 19IKB771
  • Lot Number 19JKB511
  • Lot Number 20AKC285
  • Lot Number 20CKA142
  • Lot Number 20EKA118
  • Lot Number 20EKB817
  • Lot Number 20FKA173
  • Lot Number 20HKC130
  • Lot Number 20LKA046
  • DYNJ0373061J
  • Lot Number 21IBN110

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 81 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 81 products in this recall →

Related recalls

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