Device 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.
Z-2759-2016
Product summary
- Firm
- Teleflex Medical
- Event
- Event 75020
- Status
- Terminated
- Classification
- Class II
- Quantity
- 49 units
- Official record key
device-enforcement:Z-2759-2016
Official wording
Reason: Misbranded: Incorrect etching on the device.
Code information: Product Code: 337111, Lot Number: 06F1515745.
Distribution pattern: Worldwide Distribution US Nationwide in the states of FL, IL, KY, MI, NY and OK and countries of Mexico and Canada.
Derived failure modes
-
Labeling or packaging
Misbranded