Date Initiated by Firm | March 22, 2023 |
Date Posted | April 26, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-1463-2023 |
Recall Event ID |
92004 |
510(K)Number | K201805 |
Product Classification |
Laparoscope, general & plastic surgery - Product Code GCJ
|
Product | VersaOne 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 Contact | Technical 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 |
Action | An 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 Commerce | 145 units |
Distribution | Worldwide - US Nationwide distribution in the states of NC and the countries of Belgium, Denmark, France, Germany, India, Italy, Netherlands, Spain, Sweden.
|
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.
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510(K) Database | 510(K)s with Product Code = GCJ
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