Medline Shoulder CDS convenience kits, REF DYNJ902837D and REF DYNJ902837F, containing expired component NaCl 3000mL Irrigation Bag (exp. date 08/01/2020).
- Company
- Medline Industries Inc
- Recall Initiated
- July 1, 2021
- Terminated
- March 2, 2023
- Recall Number
- Z-2231-2021
- Quantity
- 286 kits total for all products
- Firm Location
- Northfield, IL
Reason for Recall
The kits may contain an expired component.
Distribution
US Nationwide distribution in the states of MN, NE, and PA.
Lot / Code Info
REF DYNJ902837D - Lot 19IBE968, exp. 2020-09-30, GTIN (01)10193489720549; and REF DYNJ902837F - Lot 20LBU450, Exp. 2021-07-31, GTIN (01)10193489357233.
Root Cause
Employee error
Action Taken
Consignees were notified by letter dated and issued on 7/1/2021 via first class mail. The letter informed the consignee the convenience kits were being recalled due to the irrigation bag expiring August 21,2020. The consignee was to immediately check their stock for the affected kit and kit lot number and affix the enclosed sticker on the kit which instructs the consignee to remove the expired irrigation bag and replace it with sterile product from their supply. The remainder of the components may be used.