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U.S. Department of Health and Human Services

Class 2 Device Recall Covidien Endo Peanut 5mm Auto Suture Blunt Dissector

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  Class 2 Device Recall Covidien Endo Peanut 5mm Auto Suture Blunt Dissector see related information
Date Initiated by Firm May 09, 2017
Create Date June 23, 2017
Recall Status1 Terminated 3 on February 13, 2019
Recall Number Z-2622-2017
Recall Event ID 77300
510(K)Number K931962  
Product Classification Laparoscope, general & plastic surgery - Product Code GCJ
Product Covidien Endo Peanut 5mm Auto Suture Blunt Dissector
Item Code: 173019
The instrument has indications in endoscopic surgery for swabbing small amounts of fluid or for blunt dissection of soft tissue(s) and structures, or as an aid in controlling minor intraoperative bleeding
Code Information Lot Numbers: M5K04X to M7A01X Exp Date: 2020-October through 2022-January
Recalling Firm/
Manufacturer		 Covidien LLC
60 Middletown Ave
North Haven CT 06473-3908
For Additional Information Contact SAME
203-492-5000
Manufacturer Reason
for Recall		 Cotton tip of the device may disengage due to insufficient adhesive
FDA Determined
Cause 2		 Process control
Action Medtronic consignees were notified via Federal Express or certified mail on May 9, 2017, and the letter informs customers of the potential for the tip of the device to disengage from the device and the actions they should take. Accounts requested to discontinue use, quarantine and return product. Customers are requested to complete and acknowledge receipt of the Urgent Field Corrective Action Notice. Questions regarding this communication, please contact your Medtronic representative or Customer Service at 800-962-9888, option 2. For questions regarding this recall call 203-492-5000.
Quantity in Commerce 194,851
Distribution Nationwide Distribution
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 = GCJ and Original Applicant = UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
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