Recall Z-2759-2016
Teleflex Medical · initiated August 24, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
WECK Horizon" Manual-Load Ligating Clip Applier, For Medium-Large Size Horizon Ligation Clips Curved Jaw, 11 (28cm), Rx Only, REF 337111, Product Usage: Weck Closure Systems applier has been designed and calibrated for use with specific Horizon, Hemoclip Plus Hemoclip Traditional, or Atrauclip ligating clips as indicated. Applier color coding matches the color of the ligating clip cartridge for which it is to be used. Hemoclip Plus appliers are easily identified by one black-ring handle.
Codes / lots: Product Code: 337111, Lot Number: 06F1515745.
Reason for recall
Misbranded: Incorrect etching on the device.
FDA-determined cause: Error in labeling
Action taken
Teleflex sent an Urgent Medical Device Notification letter dated August 24, 2016 to customers via FedEx. The letter identified the affected product, problem and actions to be taken. For questionscontact your local sales representative or Customer Service at 1-866-246-6990.
Details
- Recall number
- Z-2759-2016
- Initiated
- August 24, 2016
- Posted by FDA
- September 8, 2016
- Terminated
- August 25, 2017
- Product code
- GDO – Applier, Surgical, Clip
- Quantity
- 49 units
- Distribution
- Worldwide Distribution US Nationwide in the states of FL, IL, KY, MI, NY and OK and countries of Mexico and Canada.
- Recalling firm
- Teleflex Medical, Research Triangle Park, NC