ORCA FOAM STANDARD CUBE 10x10x10 mm, Absorbable Gelatin Sponge Hemostat, USP, REF ORCA FOAM
Summary
The FDA issued a Class II for ORCA FOAM STANDARD CUBE 10x10x10 mm, Absorbable Gelatin Sponge Hemostat, USP, RE by GELITA MEDICAL GMBH. Reason: In routine bioburden testing, higher than acceptable levels of Endotoxins were observed..
Details
Source
Device Recall
External ID
Z-1768-2022
Action Date
2022-09-28
Status
Completed
Category
device
Product Description
ORCA FOAM STANDARD CUBE 10x10x10 mm, Absorbable Gelatin Sponge Hemostat, USP, REF ORCA FOAM
Lot/Code Info: UDI/DI 00860003109915, Batch Numbers: T02371/1, expiration date 10.02.2026; T02371/2, expiration date 10.02.2026; T02395/1, expiration date 07.05.2026; T02394/2, expiration date 07.05.2026
Quantity Affected: 3596 boxes of 50 devices
Reason for Recall
In routine bioburden testing, higher than acceptable levels of Endotoxins were observed.
Distribution
US Nationwide distribution in the state of Alabama.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-07-27
Company
Eberbach, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 145 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (GELITA MEDICAL GMBH) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does GELITA MEDICAL GMBH have FDA actions?
This is the only FDA action we have on record for GELITA MEDICAL GMBH in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1768-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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