Blunt Hurd Cannula Blunt Tip 10 mm with 5 mm Reducer simplifies open laparoscopy.
FDA device recall Z-0147-2015 · posted 2014-10-29 · Terminated
Recall details
- Recalling firm
- CooperSurgical, Inc. D.B.A. Lone Star Medical Products
- Reason for recall
- CooperSurgical is recalling two lots of 900-863 because the wrong package insert (IFU) was placed into the shipper.
- Action taken
- CooperSurgical sent an Urgent Field Safety Notice ( Correction ) dated September 27, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The recalling firm provided correct package inserts (IFU) to affected consignees. The recalling firm intends to conduct effectiveness checks by reviewing return receipts from the initial recall communication. We apologize for any inconvenience this communication may cause. If you have any questions or concerns, please contact CooperSurgical at (203) 601-9818.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- DRC
- Quantity affected
- 90 units
- Distribution
- Worldwide Distribution: US (nationwide) to North Carolina; and Internationally to Australia and Italy.
- Date initiated
- 2013-09-13
- Date posted
- 2014-10-29
- Date terminated
- 2015-09-23
- Location
- Stafford, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SURGICAL TROCAR (K911462) | Applied Medical | 1991-04-22 |