MILEX PESSARY KIT; Model Numbers: MXPES00; MXKPES00; MXKPREG03; MXKPGSK07 Product Usage: The Coopersurgical MILEX SILICO
FDA device recall Z-0253-2016 · posted 2015-11-10 · Terminated
Recall details
- Recalling firm
- CooperSurgical, Inc.
- Reason for recall
- The products have been identified to have incorrect size prints on the MILEX PESSARY KIT packaging. While the Pessary pouch is marked with correct size, an incorrect label on the packaging does not meet the required release specification.
- Action taken
- Cooper Surgical sent an Urgent Medical Device Recall letter dated September 14, 2015 via FedEx with confirmed delivery receipt. The letter identified the affected product, problem and actions to be taken. Customers were asked to discontinue use of the affected products and complete the Acknowledgement and Receipt form for a free replacement. For questions contact Product Surveillance at 203.601.5200 ext. 3300.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- HHW
- Quantity affected
- 144 units
- Distribution
- Worldwide Distribution - US Nationwide in the states of AR, CA, CO, GA, IL, KY, LA, MA, MD, MI, MT, NC, NY, OH, OK, PA, RI, SD, VA, WA, WI,WV and in the countries of FRANCE and VIETNAM.
- Date initiated
- 2015-09-14
- Date posted
- 2015-11-10
- Date terminated
- 2016-01-08
- 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 |