FDA Enforcement
Class II
Ongoing
MEDLINE M1S0179 STRL TAPE/PEN PACK, Product Code P519582A
Recall: Z-1452-2024
·
Reported April 10, 2024
Enforcement
- Recall Number
- Z-1452-2024
- Event ID
- 94136
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- MEDLINE INDUSTRIES, LP - Northfield
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- April 10, 2024
- Initiation Date
- February 23, 2024
- Classification Date
- March 29, 2024
- Address
- 3 Lakes Dr, Northfield, IL, 60093-2753, United States
Description
MEDLINE M1S0179 STRL TAPE/PEN PACK, Product Code P519582A
Reason
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
Code Info
UDI/DI 20193489111375 (case) 10193489111378 (each), Lot Numbers: 2023031590, 2023070390
Distribution
Worldwide distribution - US Nationwide and the countries of Panama, Canada.
Quantity
4200 units