Procedure packs: (1) Medline Sterile Arthroscopy Pack, REF: DYNJ64242B; (2) Medline Sterile Shoulder Pack, REF: DYNJ64250A; and (3) Medline Sterile Upper Extremity Pack, REF: DYNJ64253B.
- Recall Initiated
- April 21, 2023
- Posted
- May 26, 2023
- Recall Number
- Z-1646-2023
- Quantity
- 342 packs (114 packs/product)
- Firm Location
- Northfield, IL
Reason for Recall
The kits were damaged by water.
Distribution
Distribution was made to California. There was no foreign/government/military distribution.
Lot / Code Info
(1) Arthroscopy Pack - Lot #22HMD098, Exp. 2024-04-30, UDI/DI (01)10193489956405; (2) Shoulder Pack -Lot #22JMA673, Exp. 2024-01-31, GTIN (01)10193489429817; and (3) Upper Extremity Pack - Lot #HMF900, Exp. 2024-01-31, UDI/DI (01)10193489968453.
Root Cause
Under Investigation by firm
Action Taken
The recalling firm issued the recall letter dated 4/21/2023 via email on 4/21/2023. The letter informed the customer the packs were exposed to water, potentially affecting the sterility of the item, and that they should be destroyed for credit. The consignee was requested to immediately check their stock for the affected item number and the lot numbers listed on the recall portal. A link was provided to access the response form to list the quantity of affected product in inventory. Upon completion of the form, the consignee was to destroy the affected product. If the consignee is a distributor or have resold or transferred the product to another company or individual, they were to notify them of this recall communication and have the customer document and destroy any affected product.