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Terminated

ORCA FOAM STANDARD CUBE 10x10x10 mm, Absorbable Gelatin Sponge Hemostat, USP, REF ORCA FOAM

FDA Recall Z-1768-2022 · Posted None

Recalling FirmGELITA MEDICAL GMBH
Recall StatusTerminated
Product CodeLYA
Date Initiated2022-07-27
Date Terminated2026-09-22
Product Quantity3596 boxes of 50 devices

Reason for Recall

In routine bioburden testing, higher than acceptable levels of Endotoxins were observed.

Firm Action

The firm emailed a Field Safety Notice to the sole consignee, a distributor, on 07/27/2022, 08/11/2022 and 08/15/2022. The first letter explained the problem, hazard, and requested the return of the product. If the product was further distributed to notify customers. The second and third letters requested that the recalled articles be destroyed.

Root Cause

Under Investigation by firm

Distribution Pattern

US Nationwide distribution in the state of Alabama.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K060878GELITA-SPON ABSORBABLE GELATIN SPONGE, USPCuramedical, BV · 2006-04-13

Official Source

View FDA Recall →

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

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