Recall Z-0563-05 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
TissueLink Medical, Inc.
Tissuelink Dissecting Sealer DS3.5-C, Sterile Ref 13-121-1
| Date | Feb 25, 2005 (initiated Feb 7, 2005) |
| Status | Terminated |
| Reason | The tip may separate from the device and render it unusable |
| Root cause | Other |
| Action | TissueLink notified consignees by Federal Express Letter from 2/7/05 to 2/8/05. Users are requested to return devices in inventory. |
| Quantity | 588 units |
| Distribution | AZ, CA, CO, CT, DE, IL, FL, KS, KY, OH, MA, MD MO,NC, NY, PA, RI, SC, TN,TX, VA Foreign: Italy, Turkey, Egypt, Spain, Peru, Portugal, Australia, Netherlands Government: VA Medical Center 508 Fulton Street Durham, NC 27005 VA Medical Center- 7400 Merton Minter Blvd San Antonio, TX 78229 VA Medi |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K014260 | TISSUELINK SOLID CYLINDER MONOPOLAR DEVICE Tissuelink Medical, Inc., Mar 27, 2002 |