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Terminated

MILEX OMNIFLEX DIAPHRAGM SIZE 80 Model: MXWF80

FDA Recall Z-1814-2015 · Posted 2015-06-18

Recalling FirmCooperSurgical, Inc.
Recall StatusTerminated
Product CodeHDW
Date Initiated2015-05-20
Date Terminated2016-01-20
Product Quantity200 units

Reason for Recall

A diaphragm size 80 labeled box was incorrectly packaged with a size 85.

Firm Action

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

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K063223MILEX CONTRACEPTIVE DIAPHRAGM, OMNIFLEX DIAPHRAGMS, ARCING DIAPHRAGMS, WIDESEAL DIAPHRAGMSCooperSurgical, Inc. · 2008-01-23

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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