Reported Oct 29, 2014 · Terminated
GYRUS ACMI, REF 3345 -Everest BiCOAG MOLly Forceps 5mm/45cm REF 3345PK - PKS MOLly Forceps 5mm/45cm REF 3640 -Everest…
Gyrus Medical, Inc.
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: Gyrus Medical, Inc · 6655 Wedgwood Rd N Ste 160 · Osseo, MN · 55311-3613
Is this the product you have?
6 of 6 products
| Model / number | Product as published |
|---|---|
3345 | Everest BiCOAG MOLly Forceps 5mm/45cm |
3345PK | PKS MOLly Forceps 5mm/45cm |
3640 | Everest BiCOAG Macro Jaw Forceps 5mm/45cm |
3640PK- | PKS Macro Jaw Forceps 5mm/45cm |
3844- | Everest BiCOAG LP Scissors 5mm/45cm |
910010PK- | PKS MOLly Forceps 5mm/45cm Single-use, sterile devices intended for the electrosurgical coagulation, mechanical grasping, and dissection of tissue during the performance of laparoscopic and general surgical procedures. |
- Lot codes and dates
All product manufactured before July 282014
- Amount recalled
- 5520 US, 40 OUS
Where it was sold
Why it was recalled
Due to an anomaly in the packaging process, it is possible that a defective seal could be present that may allow a breach of the package's sterile barrier and may compromise the sterility of the product.
This product could cause temporary or reversible health problems — stop using it.
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