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Class 2 Device Recall TAMPA CATHETER 5 French 33 cm. |
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Date Initiated by Firm |
May 13, 2014 |
Date Posted |
June 11, 2014 |
Recall Status1 |
Terminated 3 on May 28, 2015 |
Recall Number |
Z-1782-2014 |
Recall Event ID |
68317 |
510(K)Number |
K970492
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Product Classification |
Cannula, manipulator/injector, uterine - Product Code LKF
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Product |
Cooper Surgical TAMPA CATHETER 5 French 33 cm. Intended for Hysterosonography. Model Number: 61-2005 |
Code Information |
Lot 141525 |
Recalling Firm/ Manufacturer |
CooperSurgical, Inc. 75 Vista Pl Trumbull CT 06611-3934
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For Additional Information Contact |
203-601-5200
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Manufacturer Reason for Recall |
Sterility of the device may be compromised due to unsealed pouch
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FDA Determined Cause 2 |
Process control |
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. |
Quantity in Commerce |
1180 units |
Distribution |
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. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = LKF and Original Applicant = ACKRAD LABORATORIES
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