Starion Instruments TLS3 35C Thermal Ligating Shears, Electrosurgical cutting and coagulation device and accessories, ma
FDA device recall Z-1969-2010 · posted 2010-07-08 · Terminated
Recall details
- Recalling firm
- Starion Instruments
- Reason for recall
- Some jaws exhibited lack of ductility and could break if overloaded or used improperly by placing too much tissue in the bottom of the "v" of the jaw.
- Action taken
- The firm called domestic consignees but no letter was sent to domestic cosignees and a notification letter was sent to international consignees. The firm called domestic consignees and sent a notification letter to international consignees. No records were kept of phone calls and a copy of the letter sent to international consignees was not obtained
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- GEI
- Distribution
- Worldwide distribution
- Date initiated
- 2008-02-06
- Date posted
- 2010-07-08
- Date terminated
- 2010-11-27
- Location
- Sunnyvale, CA
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