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U.S. Department of Health and Human Services

Class 2 Device Recall Covidien Surgiwand" II Suction and Irrigation Device

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  Class 2 Device Recall Covidien Surgiwand" II Suction and Irrigation Device see related information
Date Initiated by Firm March 05, 2021
Create Date April 12, 2021
Recall Status1 Open3, Classified
Recall Number Z-1411-2021
Recall Event ID 87542
510(K)Number K961771  
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
Product Covidien Surgiwand" II Suction and Irrigation Device: Electrosurgical, cutting & coagulation & accessories22
Product Number/CFN: 178083, 178093, 178094
Code Information UDI-Device Identifier (GTIN/UPN): 10884523000887, 20884523000884 UDI-Device Identifier (GTIN/UPN): 10884523000900, 20884523000907 UDI-Device Identifier (GTIN/UPN): 10884523000917, 20884523000914
Recalling Firm/
Manufacturer		 Covidien
201 Sabanetas Industrial Park
Building 911-67
Ponce PR 00716
For Additional Information Contact Bryan Dannettell
303-530-6383
Manufacturer Reason
for Recall		 Investigations related to customer complaints received for particulate matter inside of the Surgiwand" II device tubing components identified the root cause as a damaged Y-Connector component which connects the tubing to the device. This damage was determined to generate the particulate matter observed and is created during the assembly process for connecting the tubing component to the Y-Connector.
FDA Determined
Cause 2		 Process design
Action On 3/10/2021, Medtronic issued an Urgent Medical Device Recall notices to customers. All consignees were notified by letter delivered via Federal Express and/or certified mail. The letter informs customers of the recall of specific item codes and production lots of Covidien Surgiwand" II Suction and Irrigation Device following reports from customers of foreign particles in the device tubing.
Quantity in Commerce 59,828 devices
Distribution Domestic: AK, AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NY, OH, OR, PA, SC, TX, UT, WA, WI, WV. Foreign: Canada, Japan, Taiwan, Australia, New Zealand, Indonesia, Thailand, Singapore, Malaysia, Philippines, Bahamas, Brazil, Chile, El Salvador, Guatemala, Jamaica, Mexico, Panama, Peru, Puerto Rico, Trinidad And Tobago, Austria, Belgium, Bosnia And Herzegovina, Canary Islands, Cyprus, Denmark, Equatorial Guinea, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Kosovo, Kuwait, Lebanon, Mauritius, Netherlands, Norway, Poland, Portugal, Qatar, Romania, Russian Federation, Rwanda, Saudi Arabia, South Africa, Spain, Swaziland, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = GEI and Original Applicant = UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
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