FDA Enforcement
Class I
Ongoing
MEDLINE ARTERIAL BUNDLE NO CATHETER, REF ART995
Recall: Z-1094-2024
·
Reported March 6, 2024
Enforcement
- Recall Number
- Z-1094-2024
- 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 ARTERIAL BUNDLE NO CATHETER, REF ART995
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
UDI/DI 20193489190509 (case), 10193489190502 (unit), Lot Numbers: 2022050650
Distribution
Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama