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Terminated

Pilling Wecksorb Cylindrical Sponges

FDA Recall Z-0772-2023 · Posted 2022-12-28

Recalling FirmTELEFLEX LLC
Recall StatusTerminated
Product CodeEFQ
Date Initiated2022-09-28
Date Terminated2026-07-24
Product Quantity1,000 units

Reason for Recall

Specific lots have not been irradiated to eliminate pyronema and therefore the sterility of the affected products may be compromised.

Firm Action

Consignees were notified on about 09/28/2022, via letter. Consignees were instructed to immediately discontinue use and quarantine the products on hand, complete and return the enclosed Acknowledgement Form via fax to 1-855-419-8507 or email to [email protected]. A customer service representative will contact you with a Return Goods Authorization (RGA) number and provide instructions for the return of products.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Domestic distribution to IL, MS, PA, TN.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K791871NEUROLOGICAL SPONGES (PATTIES)Carwild Corp. · 1979-11-05

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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