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Recall Observatory FDA recall evidence

Device product

Centurion Kits, trays, and packs labeled as follows: a) DIALYSIS ACCESSORY PACK W/O CATHETER, REF MNS10750A; b) DIALYSIS ON KIT, REF DT21235A; c) INFUSA PORT KIT, REF DYNDC3166A

Z-1130-2024

November 15, 2023

Class I

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 93800
Status
Ongoing
Classification
Class I
Quantity
10391 units
Official record key
device-enforcement:Z-1130-2024

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 MNS10750A, UDI/DI 00653160348286 (case), 10653160348283 (unit), Lot Numbers: 2022032150, 2022053150, 2022061750, 2022073050; b) REF DT21235A, UDI/DI 00653160348453 (case), 10653160348450 (unit), Lot Numbers: 2022012701; c) REF DYNDC3166A, UDI/DI 00653160350111 (case), 10653160350118 (unit), Lot Numbers: 2022021150, 2022031450, 2022031850

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