FDA Enforcement
Class II
Terminated
Medline Knee Arthroscopy Kit, convenience kit, REF DYNJ902838C, containing expired component NaCl 3000mL Irrigation Bag (exp. date 08/01/2020).
Recall: Z-2232-2021
·
Reported August 18, 2021
Enforcement
- Recall Number
- Z-2232-2021
- Event ID
- 88268
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Medline Industries Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 18, 2021
- Initiation Date
- July 1, 2021
- Classification Date
- August 9, 2021
- Termination Date
- March 2, 2023
- Address
- 3 Lakes Dr, N/A, Northfield, IL, 60093-2753, United States
Description
Medline Knee Arthroscopy Kit, convenience kit, REF DYNJ902838C, containing expired component NaCl 3000mL Irrigation Bag (exp. date 08/01/2020).
Reason
The kits may contain an expired component.
Code Info
Lot 19WBA897, Exp. 2020-12-31, GTIN (01)10193489225143.
Distribution
US Nationwide distribution in the states of MN, NE, and PA.
Quantity
286 kits total for all products