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