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Recall Observatory FDA recall evidence

Device product

MEDLINE Kits, trays, and packs labeled as follows: a) ENDO KIT, REF DYKE1350D; b) PANENDOSCOPY-LF, REF DYNJ36728C; c) UMBILICAL VESSEL INSERTION, REF UVT1170; d) UMBILICAL VESSEL INSERTION, REF UVT1170H

Z-1106-2024

November 15, 2023

Class I

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 93800
Status
Ongoing
Classification
Class I
Quantity
1184 units
Official record key
device-enforcement:Z-1106-2024

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 DYKE1350D; UDI/DI 40193489339797 (case), 10193489339796 (unit), Lot Numbers: 22FBT089, 22LBN853, 23CBI535, 23DBQ149, 23EBI601; b) REF DYNJ36728C; UDI/DI 40193489265911 (case), 10193489265910 (unit), Lot Numbers: 22BBJ543, 22FBD924, 22HBR956, 23BBF230, 23FBG752; c) REF UVT1170; UDI/DI 40653160991244 (case), 10653160991243 (unit), Lot Numbers: 21LBK307, 22DMH696; d) REF UVT1170H; UDI/DI 40653160991244 (case), 10653160991243 (unit), Lot Numbers: 21LBK307, 22DMH696

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