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Terminated

Cooper Surgical TAMPA CATHETER 5 French 33 cm. Intended for Hysterosonography. Model Number: 61-2005

FDA Recall Z-1782-2014 · Posted 2014-06-11

Recalling FirmCooperSurgical, Inc.
Recall StatusTerminated
Product CodeLKF
Date Initiated2014-05-13
Date Terminated2015-05-28
Product Quantity1180 units

Reason for Recall

Sterility of the device may be compromised due to unsealed pouch

Firm Action

Cooper Surgical Inc notified consignees by letter dated 5/13/14 sent via Federal Express with confirmed delivery receipt. Consignees are requested to return for refund or exchange. If you have any further questions contact the firm at 203.601.5200.

Root Cause

Process control

Distribution Pattern

Distributed USA (nationwide) including the states of CO, CT, MO, VT, NY, OH, NJ, FL, NC, VA, AL, MA, PA, and CA, and the country of Canada.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K970492INTRAUTERINE INSEMINATION AND SONOHYSTEROGRAPHY CATHETERAckrad Laboratories · 1997-04-09

Official Source

View FDA Recall →

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

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