RecallDepth

Medline HOI LUMBAR REF DYNJ902823G Lot 20AKA895 Expiration 2021-05-31 1 each GTIN (01)10193489219180

Company
Medline Industries Inc
Recall Initiated
January 21, 2020
Posted
February 11, 2020
Terminated
January 12, 2023
Recall Number
Z-1357-2020
Quantity
122
Firm Location
Northfield, IL

Reason for Recall

The sterile pack inside the Complete Delivery System (CDS) did not go through a complete sterilization cycle, therefore the sterility of these components cannot be guaranteed.

Distribution

California only. No governmental, Canadian or Mexican consignees. TORRANCE MEMORIAL MEDICAL 3105 LOMITA BLVD TORRANCE CA 905055108 HOAG MEMORIAL HOSPITAL 1 HOAG DR NEWPORT BEACH CA 926634162 OWENS/MINORVMI TEM (65) 5125 ONTARIO MILLS PKWY ONTARIO CA 917645103

Lot / Code Info

REF DYNJ902823G Lot 20AKA895 Expiration 2021-05-31 1 each GTIN (01)10193489219180

Root Cause

Under Investigation by firm

Action Taken

Consignees were notified by telephone on 01/21/2020 followed by an e-mail on 01/22/2020 and 02/05/2020 that included a formal recall letter with response form. The recall letter identified the affected product and requested the user to quarantine the product for subsequent pick up by Medline Industries Inc. Consignee was asked to complete and return Recall Response form.

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