Date Initiated by Firm | February 26, 2013 |
Date Posted | April 03, 2013 |
Recall Status1 |
Terminated 3 on June 12, 2014 |
Recall Number | Z-1053-2013 |
Recall Event ID |
64528 |
510(K)Number | K910253 |
Product Classification |
Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
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Product | LEEP REDIKIT Product No. 6060
In a Loop Electrosurgical Excision Procedure, a thin, low-voltage electrified wire loop is used to cut out abnormal cervical tissue. The cartridges of Polocaine and Xylocaine with Epinephrine contained in the LEEP RediKit are local anaesthetic which the physician may choose from during the procedure. |
Code Information |
Lot 120716, exp 8-31-13; Lot 116657 exp. 6-30-13; Lot 116658 exp. 5-31-13; Lot 116659 exp. 7-31-13 |
Recalling Firm/ Manufacturer |
Cooper Surgical, Inc. 75 Corporate Dr Trumbull CT 06611-1350
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For Additional Information Contact | 203-601-9818 |
Manufacturer Reason for Recall | LEEP RediKit Products (for use in Loop Electrosurgical Excision Procedures) have Xylocaine (Lidocaine) HCL (2%) listed on the tray lid label but this is not included in the contents of the kit, which contained Polocaine (Mepivacaine) HCL (3%) instead (which was not listed on the tray label). |
FDA Determined Cause 2 | Labeling mix-ups |
Action | CooperSurgical sent a Recall Notification dated February 26, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
CSI intends to track and quarantine returned product in a segregated location at its manufacturing facility to ensure its separation from acceptable product and prevent its misuse. CSI intends to render used product useless by physical destruction and to rework unused product by correcting the labeling for redistribution.
If you have any one of these affected lot numbers in your current inventory, please contact our Customer Service Department at 800-243-2974, or simply complete the attached form and fax to 800-262-0105. Arrangements will be made to replace product in your possession at CooperSurgical's expense. Further instruction and disposition of product will be communicated to you at that time.
CooperSurgical deeply regrets the inconvenience that this problem has caused. |
Quantity in Commerce | 4395 kits |
Distribution | Nationwide Distribution including Puerto Rico |
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 = MQB
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