RUSCH Easy Cath Coude Kit, 10 FR, Rx Only, Sterile, Distributed by: Teleflex Medical, Research Triangle Park, NC 27708.
FDA device recall Z-1732-2014 · posted 2014-06-09 · Terminated
Recall details
- Recalling firm
- Teleflex Medical
- Reason for recall
- Product was packaged with a straight catheter rather than the correct coude (curved) catheter.
- Action taken
- Teleflex Medical sent an Urgent Medical Device Recall Notification dated May 21, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to immediately discontinue use and quarantine any of the affected product in stock. They were to complete and return the enclosed Recall Acknowledgement Form via fax to Teleflex Medical. Upon receipt, they will be contacted by a Customer Service Representative with instructions for the return of the product to Teleflex Medical. Teleflex Medical is committed to providing high quality, safe and effective products. We sincerely apologize for any inconvenience this action may cause your operations. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.
- Root cause
- Mixed-up of materials/components
- Status
- Terminated
- Product code
- KOD
- Quantity affected
- 1000 eaches
- Distribution
- US Distribution including the states of CA, FL, OH and OK.
- Date initiated
- 2014-05-21
- Date posted
- 2014-06-09
- Date terminated
- 2015-11-23
- Location
- Research Triangle Park, NC
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FLOCATH (K000070) | Rusch Intl. | 2000-02-18 |