The Recall Desk
SevereFDA (Devices)·Z-1135-2024·Announced 2024-03-06

Medline recalls Centurion Laceration Trays for potential sterility defect

Medline Industries recalls 576 units of Centurion Laceration Trays nationwide because Nurse Assist-supplied components may lack sterility, posing potential health risks 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: FDA Class I medical device recall with no reported illnesses or injuries. Per the rubric, FDA Class I recalls never score below 4. Absence of reported cases places this at Severe rather than Critical.

Plain-English summary

Medline Industries, LP is recalling certain Centurion Kits and trays (labeled as Laceration Tray, model ST11670A) because they were manufactured using specific lots of components supplied by Nurse Assist. The affected components are 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP, and Saline Flush Syringe.

Nurse Assist issued the recall due to the potential lack of sterility in these components. Because these products are used in medical procedures, non-sterile solutions pose potential health risks.

The recalled products were distributed nationwide throughout the United States (including Puerto Rico), and also to Canada, United Arab Emirates, and Panama. A total of 576 units are subject to this recall.

The recalled product

Product
Centurion Kits, trays, and packs labeled as follows: LACERATION TRAY, REF ST11670A
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Hazard
  • lack-of-sterility

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 (9)

  • a) REF ST11670A
  • UDI/DI 10653160166382 (case)
  • 00653160166385 (unit)
  • Lot Numbers: 2022042590
  • 2022111690
  • 2023020690
  • 2023040690
  • 2023063090
  • 2023091390

Distribution

Distributed nationwide across the United States.