Recall Z-1018-2013 ยท HDW Diaphragm, Contraceptive (And Accessories)
Cooper Surgical, Inc.
Omniflex Diaphragm - Size 65 (Milex Wide Seal Silicone Vaginal Diaphragm) Model MXWF65 Intended for use in contraception.
| Date | Mar 28, 2013 (initiated Feb 26, 2013) |
| Status | Terminated |
| Reason | Incorrect size was printed on the outer product packaging. |
| Root cause | Packaging |
| Action | 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 pr |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063223 | MILEX CONTRACEPTIVE DIAPHRAGM, OMNIFLEX DIAPHRAGMS, ARCING DIAPHRAGMS, WIDESEAL DIAPHRAGMS CooperSurgical, Inc., Jan 23, 2008 |