Milex Arcing Diaphragm Size 95; Model Number: MXWS95
FDA device recall Z-1054-2016 · posted 2016-03-04 · Terminated
Recall details
- Recalling firm
- CooperSurgical, Inc.
- Reason for recall
- The products have been identified to contain an incorrect size Diaphragm.
- Action taken
- Cooper Surgical sent an "Urgent - Medical Device Recall" letter dated February 16, 2016, to all affected customers. The letter identified the problem, the product and the action needed to be taken by the customer. Customers were instructed to discontinue use of the affected products and complete the attached Acknowledgement and Receipt form for replacement. For further questions, please call (203) 601-9818.
- Root cause
- Package design/selection
- Status
- Terminated
- Product code
- HDW
- Quantity affected
- 2 units
- Distribution
- US Distribution to the states of : OR and NY
- Date initiated
- 2016-02-16
- Date posted
- 2016-03-04
- Date terminated
- 2016-03-29
- Location
- Trumbull, CT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MILEX CONTRACEPTIVE DIAPHRAGM, OMNIFLEX DIAPHRAGMS, ARCING DIAPHRAGMS, WIDESEAL DIAPHRAGMS (K063223) | CooperSurgical, Inc. | 2008-01-23 |