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Recall Observatory FDA recall evidence

Device product

Medline Kits, trays, and packs labeled as follows: a) C L PREP, REF DYNJ69664; b) DMEK PREP PACK, REF DYNJ81659A; c) PRE OP KIT 1, REF DYKS1377; d) PRE OP KIT 1, REF DYKS1377A

Z-1116-2024

November 15, 2023

Class I

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 93800
Status
Ongoing
Classification
Class I
Quantity
1270 units
Official record key
device-enforcement:Z-1116-2024

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 DYNJ69664, UDI/DI 40193489966337 (case), 10193489966336 (unit), Lot Numbers: 21LBW095, 22EBT126, 22HBQ767, 22LBB063, 23EBF143; b) REF DYNJ81659A, UDI/DI 40195327277094 (case), 10195327277093 (unit), Lot Numbers: 22KBK040; c) REF DYKS1377, UDI/DI 40195327216673 (case), 10195327216672 (unit), Lot Numbers: 22LLA282; d) REF DYKS1377A , UDI/DI 40195327216673 (case), 10195327216672 (unit), Lot Numbers: 23BLA389

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