FDA Enforcement
Class I
Ongoing
Medline Kits, trays, and packs labeled as follows: C-SECTION, REF DYNJ904653G
Recall: Z-1124-2024
·
Reported March 6, 2024
Enforcement
- Recall Number
- Z-1124-2024
- Event ID
- 93800
- Classification
- Class I
- Status
- Ongoing
- Product Type
- Devices
- Firm
- MEDLINE INDUSTRIES, LP - Northfield
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 6, 2024
- Initiation Date
- November 15, 2023
- Classification Date
- February 24, 2024
- Address
- 3 Lakes Dr, Northfield, IL, 60093-2753, United States
Description
Medline Kits, trays, and packs labeled as follows: C-SECTION, REF DYNJ904653G
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 Info
REF DYNJ904653G, UDI/DI 40195327277660 (case), 10195327277659 (unit), Lot Numbers: 22KBM559, 22KBM896, 23CBU919
Distribution
Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama
Quantity
483 units