Recall Z-1768-2022— GELITA MEDICAL GMBH

Name: FDA recall Z-1768-2022
Creator: U.S. Food and Drug Administration
Published: 2022-07-27

Class II · Completed

Class II FDA medical device recall by GELITA MEDICAL GMBH, initiated 2022-07-27. It names one FDA 510(k) clearance: K060878. Product: ORCA FOAM STANDARD CUBE 10x10x10 mm, Absorbable Gelatin Sponge Hemostat, USP, REF ORCA FOAM. Reason: In routine bioburden testing, higher than acceptable levels of Endotoxins were observed..

Recalling firm: GELITA MEDICAL GMBH
Classification: Class II
Status: Completed
Initiated: 2022-07-27
Firm location: Eberbach, N/A, Germany

510(k) clearances named in this recall

1 on FDA's record

K060878 — GELITA-SPON ABSORBABLE GELATIN SPONGE, USPCuramedical, BV·cleared 2006-04-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.