Thyroid Pack CKHA-LF, Model DYNJ50352B - Product Usage: This is a type of convenience kit used in various surgeries including cardiac, abdominal, and neck surgeries.
FDA Recall Z-0781-2021 · Posted None
Recalling FirmMedline Industries Inc
Recall StatusTerminated
Product CodeOGR
Date Initiated2020-11-13
Date Terminated2021-10-26
Product Quantity40
Reason for Recall
The cylindrical sponge component is not x-ray detectable.
Firm Action
Customers were notified by email on 11/13/2020. Customers are asked to return the response form via fax or email. The recalling firm will send subsequent letters to consignees that have not provided a response to the recall notification within the allotted time.
No product is to be returned to Medline Industries. Consignees are instructed to apply labels to their affected kits and return to inventory. The label indicates that there is a recalled component within the pack, not to use it, and replace from a different sterile supply. No other components within the kit are affected.
Root Cause
Process control
Distribution Pattern
Foreign distribution only - Canada.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.