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U.S. Department of Health and Human Services

Class 3 Device Recall LEEP Patient Return Pads

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  Class 3 Device Recall LEEP Patient Return Pads see related information
Date Initiated by Firm August 19, 2019
Create Date September 16, 2019
Recall Status1 Terminated 3 on July 14, 2020
Recall Number Z-2545-2019
Recall Event ID 83704
510(K)Number K120476  
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
Product LEEP Return Patient Pads (10/ box)
Model # 6050Pl
used in electrosurgical procedures.
Code Information Lot # 201809125 & 201809135
Recalling Firm/
Manufacturer		 CooperSurgical, Inc.
95 Corporate Dr
Trumbull CT 06611-1350
For Additional Information Contact Customer Service - CooperSurgical, Inc
203-601-5200
Manufacturer Reason
for Recall		 Discrepancy between the correct expiration dates on the individual pouches inside the boxes and incorrect expiration dates on the outer boxes, where the month and day were reversed.
FDA Determined
Cause 2		 Under Investigation by firm
Action Firm sent letter 8/19/2019. 1. Please discard the outer master 10- pack box containing barcode label . 2. Keep the individual seal pouches with correct expiration date. 3. Complete and return the acknowledgement and receipt form. 4. To return the product, Qurantine the affected product, complete and retun the acknowledegment and receipt form to CooperSurgical. If you have additional questions, please contact a CooperSurgical Product Surveillance representative at 203.601.5200 Ext. 3300 or email us at recall@coopersurgical.com.
Quantity in Commerce 4930 units
Distribution USA: AK, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, & WV. Distribution US nationwide, Canada, Colombia, Japan, & Malaysia
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = GEI and Original Applicant = CONMED CORPORATION
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