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Recall Observatory FDA recall evidence

Device product

Medline Kits, trays, and packs labeled as follows: a) BLOOD DRAW KIT, REF DYNDV2183A; b) LCPH LAB DRAW KIT, REF DYNDH1641A; c) LCPH LAB DRAW KIT, REF DYNDH1641AH; d) OB LAB COLLECTION KIT, REF DYNDH1719A;

Z-1115-2024

November 15, 2023

Class I

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 93800
Status
Ongoing
Classification
Class I
Quantity
Unavailable
Official record key
device-enforcement:Z-1115-2024

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 DYNDV2183A, UDI/DI 40195327050710 (case), 10195327050719 (unit), Lot Numbers: 22ABT635, 22ABY152, 22BBO850; b) REF DYNDH1641A, UDI/DI 40195327003273 (case), 10195327006839 (unit), Lot Numbers: 22DMB468; c) REF DYNDH1641AH, UDI/DI 40195327003273 (case), 10195327006839 (unit), Lot Numbers: 22DMB468; d) REF DYNDH1719A, UDI/DI40889942880486 (case), 10889942880485 (unit), Lot Numbers: 23ABC589, 23ABR972, 23BBS014

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