CooperSurgical PESSARY KIT-CUBE#2, 1-3/8 in , 35 mm Part Number: MXKPEC02
FDA device recall Z-1239-2015 · posted 2015-03-03 · Terminated
Recall details
- Recalling firm
- CooperSurgical, Inc.
- Reason for recall
- Incorrect size printed on the Milex Pessary Kit packaging label
- Action taken
- CooperSurgical sent an Recall Letter dated February 9, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter asked customers to contact CooperSurgical Product Surveillance Department if they had any questions. At CooperSurgical's expense, arrangements were made to replace any of the affected products that customers had on hand. CooperSurgical provided further instruction on the disposition of the product at the time of replacement. Questions contact CooperSurgical 203.601.5200.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- HHW
- Quantity affected
- 95 units
- Distribution
- Nationwide Distribution
- Date initiated
- 2015-02-09
- Date posted
- 2015-03-03
- Date terminated
- 2016-01-15
- Location
- Trumbull, CT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INFLAT-O-BALL (K904026) | Milex Products, Inc. | 1990-10-10 |