FDA Enforcement
Class II
Ongoing
Brand Name: Medline Product Name: convenience kits labeled as: LAP CHOLE Model/Catalog Number: DYNJ907150
Recall: Z-1473-2022
·
Reported August 3, 2022
Enforcement
- Recall Number
- Z-1473-2022
- Event ID
- 90516
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- MEDLINE INDUSTRIES, LP - SPT
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 3, 2022
- Initiation Date
- June 6, 2022
- Classification Date
- July 27, 2022
- Address
- 1170 S Northpoint Blvd, Waukegan, IL, 60085-6757, United States
Description
Brand Name: Medline Product Name: convenience kits labeled as: LAP CHOLE Model/Catalog Number: DYNJ907150
Reason
Kits contain leaking bottles of isopropyl alcohol
Code Info
Lot Code: 21FBJ077, 21GBJ337, 21GBJ338
Distribution
US Nationwide distribution.
Quantity
54 units