Cooper Surgical TAMPA CATHETER 5 French 33 cm. Intended for Hysterosonography. Model Number: 61-2005
FDA device recall Z-1782-2014 · posted 2014-06-11 · Terminated
Recall details
- Recalling firm
- CooperSurgical, Inc.
- Reason for recall
- Sterility of the device may be compromised due to unsealed pouch
- Action taken
- Cooper Surgical Inc notified consignees by letter dated 5/13/14 sent via Federal Express with confirmed delivery receipt. Consignees are requested to return for refund or exchange. If you have any further questions contact the firm at 203.601.5200.
- Root cause
- Process control
- Status
- Terminated
- Product code
- LKF
- Quantity affected
- 1180 units
- Distribution
- Distributed USA (nationwide) including the states of CO, CT, MO, VT, NY, OH, NJ, FL, NC, VA, AL, MA, PA, and CA, and the country of Canada.
- Date initiated
- 2014-05-13
- Date posted
- 2014-06-11
- Date terminated
- 2015-05-28
- Location
- Trumbull, CT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INTRAUTERINE INSEMINATION AND SONOHYSTEROGRAPHY CATHETER (K970492) | Ackrad Laboratories | 1997-04-09 |