Milex Vaginal-Hymenal Silicone Dilators Set of 4 P/N MX20 Product Usage: The CooperSurgical Milex Vaginal-Hymenal Silico
FDA device recall Z-2098-2015 · posted 2015-07-17 · Terminated
Recall details
- Recalling firm
- CooperSurgical, Inc.
- Reason for recall
- Incorrect expiration date on outer carton kit label
- Action taken
- CooperSurgical sent an Urgent Medicall Device Recall dated June 19, 2015 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to discontinue use of the affected products and complete the attached Acknowledgement and Receipt Form for a replacement. For questions call 203.601.5200.
- Root cause
- Incorrect or no expiration date
- Status
- Terminated
- Product code
- HDX
- Quantity affected
- 40 kits
- Distribution
- US Nationwide Distribution in the states of: CA, FL, GA, HI, IL, KY, MD, MN, NC, NY, OH, TX, VT, and W A.
- Date initiated
- 2015-06-19
- Date posted
- 2015-07-17
- Date terminated
- 2016-02-01
- Location
- Trumbull, CT
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