The Recall Desk
SevereFDA (Devices)·Z-1111-2024·Announced 2024-03-06

Medline Medical Device Kits Recalled for Potential Sterility Loss

Medline Industries is recalling 26,171 kits and trays containing potentially non-sterile irrigation solutions and syringes supplied by Nurse Assist, which could pose risks if used in medical procedures.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class I recall, which by definition indicates a reasonable probability that use of the product could cause serious adverse health consequences. The potential loss of sterility in irrigation solutions and syringes used in medical procedures poses direct risk in clinical settings.

Plain-English summary

Medline Industries, LP is recalling certain medical device kits, trays, and packs manufactured using components from Nurse Assist. These components include 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP, and Saline Flush Syringes. Approximately 26,171 units are affected by this recall.

Nurse Assist recalled these components due to potential lack of sterility. The solutions and syringes could be non-sterile, which raises concerns for patients receiving medical procedures where these products are used.

The recalled kits and trays were distributed nationwide throughout the United States as well as to Puerto Rico, Canada, the United Arab Emirates, and Panama. They are used in healthcare settings for medical procedures.

Users of these products should stop use and check lot numbers against the FDA recall notice. Those with affected products should contact Medline Industries or the FDA for instructions on return, replacement, or proper disposal.

The recalled product

Product
Medline Kits, trays, and packs labeled as follows: a) 709E RECOVERY PACK A,B,C II SS, REF DYNJ55960G; b) ABDOMEN PACK, REF DYNJ53643C; c) BAG TRUNK STOCK KIT, REF DYKM1880; d) BEDSIDE BRONCH PACK, REF DYKE1601; e) BIOPSY TRAY, REF DYNDH1242; f) BRONCH KIT, REF DYKE18
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical and Medical Kits
Hazard
Affected units
26,171

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)

  • a) REF DYNJ55960G
  • UDI/DI 40193489917827 (case)
  • 10193489917826 (unit)
  • Lot Numbers: 23ALA126
  • b) REF DYNJ53643C
  • UDI/DI 40889942615354 (case)
  • 10889942615353 (unit)
  • Lot Numbers: 22CLA226
  • 22ELA033
  • 22GLA633
  • 22JLA774
  • 23BLA613
  • 23ELA554
  • 23FLA005
  • c) REF DYKM1880
  • UDI/DI 40193489807524 (case)
  • 10193489807523 (unit)
  • Lot Numbers: 22FLA285
  • 23FLA657
  • 23HLA920

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 49 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 49 products in this recall →

Related recalls

Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield

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Same hazard · sterility loss

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