FDA Medical Device Recalls (openFDA)
CooperSurgical, Inc. D.B.A. Lone Star Medical Products: Blunt Hurd Cannula Blunt Tip 10 mm with 5 mm Reducer simplifies open laparoscopy.
- Recall number
- Z-0147-2015
- Recalling firm
- CooperSurgical, Inc. D.B.A. Lone Star Medical Products
- Product
- Blunt Hurd Cannula Blunt Tip 10 mm with 5 mm Reducer simplifies open laparoscopy.
- Status
- Terminated
- Initiated
- 2013-09-13
- Posted
- 2014-10-29
- Terminated
- 2015-09-23
- Reason
- CooperSurgical is recalling two lots of 900-863 because the wrong package insert (IFU) was placed into the shipper.
- Root cause
- Error in labeling
- Action
- 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.
- Quantity
- 90 units
- Distribution
- Worldwide Distribution: US (nationwide) to North Carolina; and Internationally to Australia and Italy.
- Lot, serial or model codes
- Lots 149460 and 149911
- 510(k) numbers
- ["K911462"]
- PMA numbers
- not on file
- Product code
- DRC
- Firm FEI
- 1627186
- Firm city
- Stafford
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28