FDA Medical Device Recalls (openFDA)
CooperSurgical, Inc.: CooperSurgical H/S CATHETER (PART # 61-5007) Intended for Hysterosonography/ Hysterosalpingography.
- Recall number
- Z-2570-2014
- Recalling firm
- CooperSurgical, Inc.
- Product
- CooperSurgical H/S CATHETER (PART # 61-5007) Intended for Hysterosonography/ Hysterosalpingography.
- Status
- Terminated
- Initiated
- 2014-07-03
- Posted
- 2014-09-05
- Terminated
- 2015-05-28
- Reason
- Unsealed pouches.
- Root cause
- Packaging process control
- Action
- Customer notification letter was sent on July 1, 2014 via UPS with confirmed delivery receipt. The letter identified the product, the problem, and the action needed to be taken by the customer. At CooperSurgical's expense, arrangements were made to replace any of the affected products that customers may have on hand. For questions contact James Keller, Vice President, Regulatory Affairs/Quality Assurance at 203-601-5200.
- Quantity
- 1,400 units
- Distribution
- Worldwide Distribution -- USA, in the states of CA, TX, IL, MI, MS, ID, NY, FL, MD, PA, OR, GA, CO, WA, NJ, HI, and NC, including DC; and the countries of the countries of Spain, England, Holland, and United Kingdom.
- Lot, serial or model codes
- Lot 153914
- 510(k) numbers
- ["K020951"]
- PMA numbers
- not on file
- Product code
- LKF
- Firm FEI
- 1216677
- Firm city
- Trumbull
- Firm state
- CT
- 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