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U.S. Department of Health and Human Services

Class 2 Device Recall VersaOne Reusable Positioning Cannula

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 Class 2 Device Recall VersaOne Reusable Positioning Cannulasee related information
Date Initiated by FirmMarch 22, 2023
Date PostedApril 26, 2023
Recall Status1 Open3, Classified
Recall NumberZ-1463-2023
Recall Event ID 92004
510(K)NumberK201805 
Product Classification Laparoscope, general & plastic surgery - Product Code GCJ
ProductVersaOne Reusable Positioning Cannula 8 mm Standard, Model Number RC8STS
Code Information UDI-DI: 10884521784024; Serial Numbers: C21RAE0063 C21RAE0064 C21RAE0065 C21RAE0072 C21RAE0074 C21RAE0032 C21RAE0033 C21RAE0035 C21RAE0036 C21RAE0037 C21RAE0039 C21RAE0054 C21RAE0055 C21RAE0062 C21RAE0073 C21RAE0075 C21RAH0001 C21RAH0002 C21RAH0003 C21RAH0004 C21RAH0005 C21RAE0051 C21RAE0052 C21RAE0053 C21RAK0024 C21RAK0025 C21RAK0026 C21RAE0044 C21RAE0045 C21RAH0012 C21RAH0017 C21RAH0018 C21RAH0019 C21RAH0020 C21RAK0001 C21RAK0002 C21RAK0003 C21RAK0004 C21RAK0005 C21RAK0007 C21RAK0012 C21RAK0013 C21RAK0014 C21RAH0006 C21RAH0007 C21RAH0008 C21RAH0009 C21RAH0010 C21RAH0011 C21RAK0006 C21RAK0010 C21RAK0011 C21RAG0006 C21RAG0007 C21RAG0008 C21RAG0009 C21RAG0010 C21RAG0011 C21RAG0012 C21RAG0013 C21RAG0014 C21RAG0015 C21RAG0016 C21RAG0017 C21RAG0018 C21RAG0019 C21RAG0020 C21RAH0016 C21RAK0021 C21RAK0022 C21RAK0023 C21RAK0027 C21RAK0028 C21RAB0023 C21RAB0024 C21RAB0025 C21RAE0001 C21RAE0002 C21RAE0003 C21RAE0004 C21RAE0005 C21RAE0006 C21RAE0007 C21RAE0008 C21RAE0009 C21RAK0029 C21RAK0030 C21RAK0031 C21RAK0042 C21RAK0043 C21RAK0044 C21RAK0045 C21RAL0001 C21RAL0002 C21RAL0003 C21RAL0004 C21RAL0005 C21RAL0006 C21RAL0007 C21RAL0008 C21RAL0009 C21RAM0001 C21RAM0002 C21RAM0005 C21RAM0006 C21RAM0042 C21RAM0048 C21RAM0052 C21RAM0053 C21RAM0091 C21RAM0092 C21RAM0093 C21RAM0094 C21RAM0095 C21RAM0096 C21RAM0097 C21RAM0098 C21RAM0099 C21RAM0057 C21RAM0058 C21RAM0060 C21RAM0061 C21RAM0062 C21RAM0063 C21RAM0064 C21RAM0065 C21RAM0066 C21RAM0067 C21RAM0068 C21RAM0069 C21RAK0032 C21RAK0033 C21RAK0034 C21RAK0035 C21RAK0036 C21RAK0037 C21RAK0038 C21RAK0040 C21RAK0041 C21RAM0079 C21RAM0080 C21RAM0081 C21RAM0082 C21RAM0083 C21RAM0084
Recalling Firm/
Manufacturer
Covidien LP
15 Hampshire St
Mansfield MA 02048-1113
For Additional Information ContactTechnical Service
508-261 Ext. 8000
Manufacturer Reason
for Recall
There is a manufacturing non-conformance that may result in a metal shaving (burr) on the inside of the VersaOneTM Reusable Positioning Cannula, located where the Cannula and Body components are welded together.
FDA Determined
Cause 2
Process control
ActionAn URGENT MEDICAL DEVICE RECALL notification letter dated March 2023 was sent to customers. Customer Actions: Our records show that your facility has received the impacted product. Medtronic requests that you take the following actions: " Identify and quarantine any used and unused impacted product. Please refer to Attachment A: Impacted Serial Number Lists for a list of affected products. For verifying the respective product and serial number on the device and packaging please refer to Attachment B. " Sterilize all used devices as per your standard decontamination protocol prior to returning used cannulas. Utilization of appropriate personal protective equipment is advisable during decontamination of the device. " Return the impacted product(s) to Medtronic following the instructions in the enclosed Customer Confirmation Form. " Complete the Customer Confirmation Form enclosed with this letter, acknowledging that you have received this information. " Forward this notification to any entities within your organization or to any other organization where the potentially affected product has been transferred or further distributed. Adverse events or quality problems experienced with this product should be reported to the FDA and Medtronic: " Online at http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm, or call FDA at 1-800-FDA-1088 (1-800-332-1088) " Medtronic Technical Services at 1-800-962-9888, option 2 to provide information regarding those events. We regret any inconvenience this may cause. We are committed to patient safety and appreciate your prompt attention to this matter. If you have any questions regarding this communication, please contact your Medtronic Field Representative.
Quantity in Commerce145 units
DistributionWorldwide - US Nationwide distribution in the states of NC and the countries of Belgium, Denmark, France, Germany, India, Italy, Netherlands, Spain, Sweden.
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 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) Database510(K)s with Product Code = GCJ
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