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Recall Observatory FDA recall evidence

Device product

MEDLINE Kits, trays, and packs labeled as follows: a) C-SECTION, REF DYNJ904653G; b) DRESSING TRAY, REF M101426; c) ENDO KIT, REF DYKE1387; d) ENDO KIT, REF DYKE1364B; e) ENDO KIT, REF DYKE1892; f) ENDO KIT W/ BLUE TOTE BAG, REF DYKE1648I; g) EYE KIT, REF DYKM2222; h) LAP CHOLE CDS, REF CDS983912Y; i) PLASTICS SUTURE TRAY, REF SUT13535; j) SNES ENDO KIT, REF DYKE1930A

Z-1103-2024

November 15, 2023

Class I

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 93800
Status
Ongoing
Classification
Class I
Quantity
5969 units
Official record key
device-enforcement:Z-1103-2024

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 DYNJ904653G, UDI/DI 40195327279951 (case), 10195327279950 (unit), Lot Numbers: 23ABE326; b) REF M101426, UDI/DI 40195327279951 (case), 10195327279950 (unit), Lot Numbers: 23ABD269; c) REF DYKE1387, UDI/DI 40889942384007 (case), 10889942384006 (unit), Lot Numbers: 22FBC677, 22FBU123, 22HBA432, 22JBG195, 23ABF156, 23BBE110, 23CBG139, 23CBU443; d) REF DYKE1364B, UDI/DI 40195327162734 (case), 10195327162733 (unit), Lot Numbers: 22FBV837, 22HBL534, 22IMH103, 22KMA408, 22LMG525; e) REF DYKE1892, UDI/DI 40195327279951 (case), 10195327279950 (unit), Lot Numbers: 23ABD211, 23CBX144, 23FBN050; f) REF DYKE1648I, UDI/DI 40195327279951 (case), 10195327279950 (unit), Lot Numbers: 23CBX187; g) REF DYKM2222, UDI/DI 40195327279951 (case), 10195327279950 (unit), Lot Numbers: 23FBO502; h) REF CDS983912Y, UDI/DI 40195327279951 (case), 10195327279950 (unit), Lot Numbers: 23FBO144 i) REF SUT13535, UDI/DI 40195327279951 (case), 10195327279950 (unit), Lot Numbers: 23CBX181; j) REF DYKE1930A, UDI/DI 40195327449224 (case), 10195327449223 (unit), Lot Numbers: 23FBR603, 23HBO128

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

Field note

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