CooperSurgical H/S CATHETER (PART # 61-5007) Intended for Hysterosonography/ Hysterosalpingography.
FDA device recall Z-2570-2014 · posted 2014-09-05 · Terminated
Recall details
- Recalling firm
- CooperSurgical, Inc.
- Reason for recall
- Unsealed pouches.
- Action taken
- 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.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- LKF
- Quantity affected
- 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
- Date initiated
- 2014-07-03
- Date posted
- 2014-09-05
- Date terminated
- 2015-05-28
- Location
- Trumbull, CT
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| H/S CATHETER SET (5F), MODEL 61-5005; H/S CATHETER SET (7F), MODEL 61-5007 (K020951) | Ackrad Laboratories | 2002-04-16 |