Milex Arcing Diaphragm Size 95; Model Number: MXWS95
FDA Recall Z-1054-2016 · Posted 2016-03-04
Recalling FirmCooperSurgical, Inc.
Recall StatusTerminated
Product CodeHDW
Date Initiated2016-02-16
Date Terminated2016-03-29
Product Quantity2 units
Reason for Recall
The products have been identified to contain an incorrect size Diaphragm.
Firm Action
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
Distribution Pattern
US Distribution to the states of : OR and NY
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.