Tissuelink Dissecting Sealer DS3.5-C, Sterile Ref 13-121-1
FDA device recall Z-0563-05 · posted 2005-02-25 · Terminated
Recall details
- Recalling firm
- TissueLink Medical, Inc.
- Reason for recall
- The tip may separate from the device and render it unusable
- Action taken
- TissueLink notified consignees by Federal Express Letter from 2/7/05 to 2/8/05. Users are requested to return devices in inventory.
- Root cause
- Other
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 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 St
- Date initiated
- 2005-02-07
- Date posted
- 2005-02-25
- Date terminated
- 2005-04-20
- Location
- Dover, NH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TISSUELINK SOLID CYLINDER MONOPOLAR DEVICE (K014260) | Tissuelink Medical, Inc. | 2002-03-27 |