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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 Dissectorsee related information
Date Initiated by FirmMay 09, 2017
Create DateJune 23, 2017
Recall Status1 Terminated 3 on February 13, 2019
Recall NumberZ-2622-2017
Recall Event ID 77300
510(K)NumberK931962 
Product Classification Laparoscope, general & plastic surgery - Product Code GCJ
ProductCovidien 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
FEI Number 1219930
Recalling Firm/
Manufacturer		 Covidien LLC
60 Middletown Ave
North Haven CT 06473-3908
For Additional Information ContactSAME
203-492-5000
Manufacturer Reason
for Recall		Cotton tip of the device may disengage due to insufficient adhesive
FDA Determined
Cause 2		Process control
ActionMedtronic 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 Commerce194,851
DistributionNationwide Distribution
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 = GCJ
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