FDA Recall
Terminated
WECK Hemoclip Traditional Medium Tantalum Ligating Clips. Weck Ligating Clips are intended for use in procedures involving vessels or anatomic structures for which the surgeon determines ligating clips are the best choice.
Recall: Z-0826-2015
·
Initiated December 3, 2014
Recall
- Recall Number
- Z-0826-2015
- Event Number
- 69918
- Firm
- Teleflex Medical
- FEI Number
- 3005747797
- Product Code
- FZP
- Status
- Terminated
- Root Cause
- Labeling Change Control
- Initiated
- December 3, 2014
- Posted
- December 17, 2014
- Terminated
- November 24, 2017
- Address
- 4024 Stirrup Creek Dr, Durham, NC, 27703-9000
Description
WECK Hemoclip Traditional Medium Tantalum Ligating Clips. Weck Ligating Clips are intended for use in procedures involving vessels or anatomic structures for which the surgeon determines ligating clips are the best choice.
Reason
The manufacturing dates and expiration dates were transposed on the Tyvek label.
Action
Consignees were notified by letter on 12/03/2014.
Distribution
US (nationwide) including the states of AL, CA, FL, DE, IA, IL, IN, KY, MA, MN, NC, NE, NJ, NY, NV, OH, OK, PA, TX, VA, VT, and WA.
Quantity
3180 units