Recalls / —
—#149127
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.
- FDA product code
- GDO — Applier, Surgical, Clip
- Device class
- Class 1
- Medical specialty
- General, Plastic Surgery
- Affected lot / code info
- Product Code: 337111, Lot Number: 06F1515745.
Why it was recalled
Misbranded: Incorrect etching on the device.
Root cause (FDA determination)
Error in labeling
Action the firm took
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.
Recalling firm
- Firm
- Teleflex Medical
- Address
- 2917 Weck Dr, Research Triangle Park, North Carolina 27709-0186
Distribution
- Distribution pattern
- Worldwide Distribution US Nationwide in the states of FL, IL, KY, MI, NY and OK and countries of Mexico and Canada.
Timeline
- Recall initiated
- 2016-08-24
- Posted by FDA
- 2016-09-08
- Terminated
- 2017-08-25
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #149127. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.