FDA Enforcement
Class II
Ongoing
Medline convenience kits labeled as: a. MIDDLE EAR PACK-LF, Model DYNJ0689093V, b. EENT PACK, Model Number DYNJ62927 Model/Catalog Number: a. DYNJ0689093V, b. DYNJ62927
Recall: Z-1472-2022
·
Reported August 3, 2022
Enforcement
- Recall Number
- Z-1472-2022
- 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. MIDDLE EAR PACK-LF, Model DYNJ0689093V, b. EENT PACK, Model Number DYNJ62927 Model/Catalog Number: a. DYNJ0689093V, b. DYNJ62927
Reason
Kits contain leaking bottles of isopropyl alcohol
Code Info
Lot Code: a. Model Number DYNJ0689093V, Lot Codes: 22DMI666, 21LBI103, 21HBO705, 21JBP781, 21JBQ762, 21FBG532, 21FBG535, b. Model Number DYNJ62927, Lot Numbers: 22BBB412
Distribution
US Nationwide distribution.
Quantity
477 units