5/10 mm Weck Vista Optical Bladeless Laparoscopic Access Port, Catalog No. 405910R; 5/10/12 mm Weck Vista Optical Bladel
FDA device recall Z-1325-2014 · posted 2014-04-02 · Terminated
Recall details
- Recalling firm
- Teleflex Medical
- Reason for recall
- Complaints of leakage of insufflation gas through the device.
- Action taken
- Letters were issued on March 11, 2014 to customers informing them of the recall. The letter asked the consignee to immediately discontinue use and quarantine any products on hand. The letter included a Recall Acknowledgement Form which is to be returned. A letter was also issued to distributors on March 11, 2014, requesting them to conduct a sub-recall.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- GCJ
- Quantity affected
- 55,521 total
- Distribution
- Worldwide Distribution-USA (nationwide) including Puerto Rico and the states of AL, AZ, AR, CA, CO, CT, FL, GA, IL, IN, KS, KY, MD, MA, MI, MN, MS, MO, NH, NJ, NY, NC, ND, OH, OR, PA, SC, TN, UT, VA,
- Date initiated
- 2014-03-11
- Date posted
- 2014-04-02
- Date terminated
- 2016-01-28
- 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 |
|---|---|---|
| WECK VISTA OPTICAL BLADELESS LAPAROSCOPIC ACCESS PORT (K121380) | Teleflexmedical, Inc. | 2012-05-25 |