Covidien, LigaSure, Blunt Tip Laparoscopic Sealer/Divider, 5 mm-37 cm, REF LF1537, Sterile EO, Covidien, Valleylab, a di
FDA device recall Z-0954-2011 · posted 2011-01-25 · Terminated
Recall details
- Recalling firm
- Covidien LP
- Reason for recall
- During surgical procedures, the device may energize when clamping without pushing the activation button, which could result in unintended energy delivery to tissue.
- Action taken
- The firm, Covidien, sent a "URGENT: PRODUCT RECALL" letter dated December 6, 2010, to the customers. The letter described the product, problem and the action to be taken by the customers. The customers were instructed to remove product from inventory, immediately quarantine the product and return any remaining stock of the lots listed to: Covidien Energy-based devices, Attention: R82, Building 4/Receiving, 5920 Longbow Drive, Boulder, CO 80301. The customers were also instructed to complete and return the Customer Response Form immediately via mail (in the envelope provided) or fax to (303) 516-8307. To return any identified product for credit or replacement, contact Customer Service at 1-800-722-8772 Option 1. Should you have any medical questions concerning this recall, please contact your local sales representative or the Covidien Clinical information Hotline at (800) 255-8522 (option 1).
- Root cause
- Device Design
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 25,009 units
- Distribution
- Worldwide distribution: USA and countries including: Australia, Canada, France, Germany, Japan, Puerto Rico, Singapore, and Uruguay.
- Date initiated
- 2010-12-08
- Date posted
- 2011-01-25
- Date terminated
- 2012-03-27
- Location
- Boulder, CO
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LIGASURE 5MM BLUNT TIP LAPAROSCOPIC SEALER-DIVIDER (K092879) | Valleylab | 2009-10-16 |