Recall Z-0954-2011 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Covidien LP
Covidien, LigaSure, Blunt Tip Laparoscopic Sealer/Divider, 5 mm-37 cm, REF LF1537, Sterile EO, Covidien, Valleylab, a division of Tyco Healthcare Group LP, 5920 Longbow Drive, Boulder, CO 80301 Intended use: LigaSure 5 mm devices are electrosurgical instruments designed to permanently seal and divide vessels, tissue bundles, and lymphatics.
| Date | Jan 25, 2011 (initiated Dec 8, 2010) |
| Status | Terminated |
| Reason | During surgical procedures, the device may energize when clamping without pushing the activation button, which could result in unintended energy delivery to tissue. |
| Root cause | Device Design |
| Action | 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) |
| Quantity | 25,009 units |
| Distribution | Worldwide distribution: USA and countries including: Australia, Canada, France, Germany, Japan, Puerto Rico, Singapore, and Uruguay. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092879 | LIGASURE 5MM BLUNT TIP LAPAROSCOPIC SEALER-DIVIDER Valleylab, Oct 16, 2009 |