Reported Jun 3, 2020 · Terminated
DR. THAMES - LAP CHOLE, REF: K0880, UDI: (01)30607915139620
Applied Medical Resources Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Applied Medical Resources Corp · 22872 Avenida Empresa · Rancho Santa Margarita, CA · 92688-2650
Is this the product you have?
- DR. THAMES - LAP CHOLE
- REFK0880
- UDI(01)30607915139620
- Lot codes and dates
- Batch1378830/Expiration
- Date
September 82022
- Batch1379253/Expiration
- Date
August 132022
- Batch1380094/Expiration
- Date
August 222022
- Batch1381695/Expiration
- Date
October 302022
- Amount recalled
- 21 units
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
There may be a slightly protruding rivet on the distal end of the laparoscopic grasper which has the potential for tissue to catch on it during use and lead to tissue damage.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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