FDA Enforcement
Class II
Ongoing
Medline Convenience kits labeled as: a. WET SKIN PREP TRAY, b. SKIN PREP TRAY W/CHG Model/Catalog Number: Model numbers: a. DYNDP1127A, b. DYNDP1131
Recall: Z-1475-2022
·
Reported August 3, 2022
Enforcement
- Recall Number
- Z-1475-2022
- 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
Medline Convenience kits labeled as: a. WET SKIN PREP TRAY, b. SKIN PREP TRAY W/CHG Model/Catalog Number: Model numbers: a. DYNDP1127A, b. DYNDP1131
Reason
Kits contain leaking bottles of isopropyl alcohol
Code Info
Lot Code: a. Model number DYNDP1127A, Lot Numbers: 22ABG455, 21FBU537, 21IBF632, 21JBY751, 21LBB154, b. Model number DYNDP1131, Lot Numbers: 22DBT130, 22DBK391, 22ABC822, 22OBE201, 21IBR746, 21JBL238, 21KBU021,
Distribution
US Nationwide distribution.
Quantity
1880 units