Omniflex Diaphragm - Size 65 (Milex Wide Seal Silicone Vaginal Diaphragm) Model MXWF65 Intended for use in contraception
FDA device recall Z-1018-2013 · posted 2013-03-28 · Terminated
Recall details
- Recalling firm
- Cooper Surgical, Inc.
- Reason for recall
- Incorrect size was printed on the outer product packaging.
- Action taken
- CSI notified consignees affected by this recall by a Recall Notification letter, dated February 26, 2013, sent via Federal Express with confirmed delivery receipt. The letter identified the affected product, and asked customers to contact the firm's Customer Service Department at 1-800-243-2974, if they had any of the affected lot in their inventory. Customers also have the option of completing the form attached to the letter and faxing it back to 800-262-0105. At CooperSurgical's expense, arrangements will made to replace the affected products that customers have on hand. The firm will provide further instruction and disposition of the product at the time of replacement.
- Root cause
- Packaging
- Status
- Terminated
- Product code
- HDW
- Quantity affected
- 80 individual diaphragms
- Distribution
- Worldwide Distribution -- USA, including the states of NE, MA, FL, TN, CA, ME, SC, CA, NH, OK, TX, NM, MO, NY, PA, and AZ, and countries of Germany, Italy, and Canada.
- Date initiated
- 2013-02-26
- Date posted
- 2013-03-28
- Date terminated
- 2014-03-04
- 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 |
|---|---|---|
| MILEX CONTRACEPTIVE DIAPHRAGM, OMNIFLEX DIAPHRAGMS, ARCING DIAPHRAGMS, WIDESEAL DIAPHRAGMS (K063223) | CooperSurgical, Inc. | 2008-01-23 |