Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall LEEP

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall LEEPsee related information
Date Initiated by FirmFebruary 26, 2013
Date PostedApril 03, 2013
Recall Status1 Terminated 3 on June 12, 2014
Recall NumberZ-1053-2013
Recall Event ID 64528
510(K)NumberK910253 
Product Classification Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
ProductLEEP 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
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
ActionCooperSurgical 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 Commerce4395 kits
DistributionNationwide Distribution including Puerto Rico
Total Product Life CycleTPLC Device Report
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.
510(K) Database510(K)s with Product Code = MQB
-
-