CooperSurgical MILEX PESSARY KITS-Ring w/Support Folding Pessary- #1 Model: MXKPRS01 Product Usage: The CooperSurgical M
FDA device recall Z-0207-2015 · posted 2014-11-13 · Terminated
Recall details
- Recalling firm
- CooperSurgical, Inc.
- Reason for recall
- Incorrect expiration date printed on the MILEX PESSARY KIT packaging
- Action taken
- CooperSurgical notified customers a Recall Notification dated September 29, 2014, via UPS . The letter identified the product problem and the action needed to be taken by the customer. CooperSurgical's will replace any of the affected and provided further instruction on the disposition of the product at the time of replacement. If you have any further questions, contact 203.601.5200. .
- Root cause
- Incorrect or no expiration date
- Status
- Terminated
- Product code
- HHW
- Quantity affected
- 17 units
- Distribution
- US Distibution in states of:OH, CA, WI, WA, FL, MN, NH, RI, MA, IL, MI, IA, and AL
- Date initiated
- 2014-09-30
- Date posted
- 2014-11-13
- Date terminated
- 2015-05-28
- 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 |
|---|---|---|
| INGLAT-O-BALL (K904774) | Milex Products, Inc. | 1990-12-07 |
| INFLAT-O-BALL (K904026) | Milex Products, Inc. | 1990-10-10 |