Z-1106-2024 Class I Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- March 6, 2024
- Initiation Date
- November 15, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1184 units
Product Description
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
Reason for Recall
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.
Distribution Pattern
Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama
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