RUSCH, GB: Robinson/Nelaton Catheter, All Purpose PVC 10 Fr. 40 cm, Distributed by Teleflex Medical, Research Triangle P
FDA device recall Z-2937-2011 · posted 2011-08-03 · Terminated
Recall details
- Recalling firm
- Teleflex Medical
- Reason for recall
- Pin holes were detected in the packaging therefore sterility of the device can not be guaranteed.
- Action taken
- Teleflex Medical sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter dated June 30, 2011 to all affected consignees. The letter described the product, problem and actions to be taken. The letter instructs the customers to discontinue use and quarantine any of the affected products. Customers were asked to complete the attached Recall Acknowledgement Form and return as per the instructions. A separate letter was sent to distributors instructing them to communicate the recall to any of their customers who may have receive the affected products, using the recall letter and form as a template. For questions, contact your local sales representative or call Customer service at 1-866-246-6990
- Root cause
- Other
- Status
- Terminated
- Product code
- KOD
- Quantity affected
- see line 1.
- Distribution
- Worldwide Distribution and (USA) Nationwide Distribution.
- Date initiated
- 2011-06-30
- Date posted
- 2011-08-03
- Date terminated
- 2014-04-29
- Location
- Durham, NC
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NELATON-, FEMALE - OR TIEMANN CATHETER (K896729) | Unoplast A/S | 1990-11-05 |