WECK Horizon" Manual-Load Ligating Clip Applier, For Medium-Large Size Horizon Ligation Clips Curved Jaw, 11 (28cm), Rx
FDA device recall Z-2759-2016 · posted 2016-09-08 · Terminated
Recall details
- Recalling firm
- Teleflex Medical
- Reason for recall
- Misbranded: Incorrect etching on the device.
- 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.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- GDO
- Quantity affected
- 49 units
- Distribution
- Worldwide Distribution US Nationwide in the states of FL, IL, KY, MI, NY and OK and countries of Mexico and Canada.
- Date initiated
- 2016-08-24
- Date posted
- 2016-09-08
- Date terminated
- 2017-08-25
- Location
- Research Triangle Park, NC
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