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Recall Observatory FDA recall evidence

Device product

Centurion Kits, trays, and packs labeled as follows: LACERATION TRAY, REF ST11670A

Z-1135-2024

November 15, 2023

Class I

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 93800
Status
Ongoing
Classification
Class I
Quantity
576 units
Official record key
device-enforcement:Z-1135-2024

Official wording

Reason: Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.

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

Distribution pattern: Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    lack of sterility