Medline Shoulder CDS convenience kits, REF DYNJ902837D and REF DYNJ902837F, containing expired component NaCl 3000mL Irrigation Bag (exp. date 08/01/2020).
FDA Recall Z-2231-2021 · Posted None
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Recalling FirmMedline Industries Inc
Recall StatusTerminated
Product CodeOJH
Date Initiated2021-07-01
Date Terminated2023-03-02
Product Quantity286 kits total for all products
Reason for Recall
The kits may contain an expired component.
Firm Action
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.
Root Cause
Employee error
Distribution Pattern
US Nationwide distribution in the states of MN, NE, and PA.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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