5/10/12 mm Weck Vista" Optical Bladeless Laparoscopic Access Port, Product Usage: An endoscope and accessories is a devi
FDA device recall Z-1283-2014 · posted 2014-03-25 · Terminated
Recall details
- Recalling firm
- Teleflex Medical
- Reason for recall
- Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures.
- Action taken
- Teleflex sent an Urgent Medical Device Recall Notification letter dated March 11, 2014 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to return all affected product to Teleflex Medical per the instructions provided in the letter. Customers were asked to complete the enclosed Recall Acknowledgment Form and fax it to 1-866-804-9881, Attn: Customer Service. For questions contact your local sales representative or Customer Service at 1-866-246-6990.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- GCJ
- Quantity affected
- 55,521 ea. in total
- Distribution
- Worldwide Distribution - USA Nationwide including Puerto Rica and the countries of: Australia, Brazil, China, Canada, Malaysia, Korea, Ireland Singapore and Vietnam.
- Date initiated
- 2014-03-11
- Date posted
- 2014-03-25
- Date terminated
- 2017-08-15
- Location
- Research Triangle Park, NC
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| WECK VISTA OPTICAL BLADELESS LAPAROSCOPIC ACCESS PORT (K121380) | Teleflexmedical, Inc. | 2012-05-25 |