Agency classClass IOur severity:Critical FDA (Devices)·Z-1120-2024·Announced 2024-03-06

Medline wound care trays recalled due to sterility defect

Medline Industries is recalling Wound Care Trays due to potential lack of sterility in solution components. The recall affects 72,624 units distributed nationwide and internationally.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: This product is classified as FDA Class I, which is a criterion for Critical severity per the rubric. FDA Class I recalls represent the agency's most serious classification level.

Plain-English summary

Medline Industries, LP is recalling Wound Care Trays (latex-free, REF DYND06002) manufactured using certain lots of Nurse Assist sterile components, including 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP, and Saline Flush Syringe. The recall affects 72,624 units.

The recall was initiated due to the potential lack of sterility in the solution components, which could result in non-sterile solutions. The affected products were distributed nationwide in the United States, as well as to Puerto Rico, Canada, the United Arab Emirates, and Panama.

The recalled product

Product: Medline Kits, trays, and packs labeled as follows: WOUND CARE TRAY - LATEX-FREE, REF DYND06002
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Category: Medical Device — Wound care tray
Hazard: lack-of-sterility
contamination-risk
Affected units: 72,624

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)

REF DYND06002
UDI/DI 40080196816645 (case)
10080196816644 (unit)
Lot Numbers: 2022041290
2022051090
2022062090
2022081190
2022081790
2022101990
2022102090
2022111490
2023050390
2023050890
2023042890
2023050490
2023063090
2023062990
2023070390
2023072890
2023082590

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 →

Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield

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Same hazard · lack of sterility