Reported Feb 14, 2018 · Terminated
The ReNew Reusable Grasper and Dissector Tips are to be used with the ReNew Laparoscopic Handpieces and they are…
Microline Surgical, 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: Microline Surgical, Inc. · 800 Cummings Ctr Ste 166T · Beverly, MA · 01915-6171
Is this the product you have?
- The ReNew Reusable Grasper and Dissector Tips are to be used with the ReNew Laparoscopic Handpieces and they are indicated for cutting, grasping, dissecting, and coagulation of tissue in endoscopic and laparoscopic surgical procedures.
- Lot codes and dates
- All lots of product codes
3201322132313241325132613271328132913301331133213331334133513361337133813401341134213431
- UDI's for listed lots of product codes
3201-UDI 008110990116443221-UDI 008110990116513231-UDI 008110990116683241-UDI 008110990116753251-UDI 008110990116823261-UDI 008110990116993271-UDI 008110990117053281-UDI 008110990117123291-UDI 008110990117293301-UDI 008110990118593311-UDI 008110990117363321-UDI 008110990117433331-UDI 008110990117673341-UDI 008110990117743351-UDI 008110990117813371-UDI 008110990118043381-UDI 008110990118113401-UDI 008110990118283411-UDI 008110990118353421-UDI 008110990118423431-UDI 00811099011644
- All lots of product codes
- Amount recalled
- 61,769 units
Where it was sold
- Nationwide
Why it was recalled
The heat-shrink insulation tube may split during autoclave sterilization/re-sterilization. If a split occurs, the heat-shrink could fall off during a surgical procedure and if cautery is needed, there is a potential for burn due to insulation failure.
This product could cause temporary or reversible health problems — stop using it.
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