MILEX OMNIFLEX DIAPHRAGM SIZE 80 Model: MXWF80
FDA device recall Z-1814-2015 · posted 2015-06-18 · Terminated
Recall details
- Recalling firm
- CooperSurgical, Inc.
- Reason for recall
- A diaphragm size 80 labeled box was incorrectly packaged with a size 85.
- Action taken
- CooperSurgical notified consignees by letter on 5/18/15 via Fedex with confirmed delivery receipt.. Accounts requested to discontinue use and complete the attached Acknowledgement and Receipt Form for replacement. CooperSurgical provided further instruction on the disposition of the product at the time of replacement If you have any further questions please feel free to contact 203.601.5200. .
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- HDW
- Quantity affected
- 200 units
- Distribution
- AK, CA, DC, FL, IL, ME, MT, NE, NJ, NM, NY, OK, OR, P A, VA, W A, and WI Foreign: CANADA, ENGLAND, and POLAND
- Date initiated
- 2015-05-20
- Date posted
- 2015-06-18
- Date terminated
- 2016-01-20
- Location
- Trumbull, CT
Monitor recalls programmatically
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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 |