FDA Enforcement
Class II
Terminated
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.
Recall: Z-2759-2016
·
Reported September 14, 2016
Enforcement
- Recall Number
- Z-2759-2016
- Event ID
- 75020
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Teleflex Medical
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 14, 2016
- Initiation Date
- August 24, 2016
- Classification Date
- September 8, 2016
- Termination Date
- August 25, 2017
- Address
- 2917 Weck Dr, Research Triangle Park, NC, 27709-0186, United States
Description
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.
Reason
Misbranded: Incorrect etching on the device.
Code Info
Product Code: 337111, Lot Number: 06F1515745.
Distribution
Worldwide Distribution US Nationwide in the states of FL, IL, KY, MI, NY and OK and countries of Mexico and Canada.
Quantity
49 units