Recall Z-2570-2014 ยท LKF Cannula, Manipulator/Injector, Uterine
CooperSurgical, Inc.
CooperSurgical H/S CATHETER (PART # 61-5007) Intended for Hysterosonography/ Hysterosalpingography.
| Date | Sep 5, 2014 (initiated Jul 3, 2014) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020951 | H/S CATHETER SET (5F), MODEL 61-5005; H/S CATHETER SET (7F), MODEL 61-5007 Ackrad Laboratories, Apr 16, 2002 |