Summary
The FDA issued a Class II for VersaOne Reusable Positioning Cannula 8 mm Standard, Model Number RC8STS by Covidien LP. Reason: There is a manufacturing non-conformance that may result in a metal shaving (burr) on the inside of the VersaOneTM Reusable Positioning Cannula, locat.
Details
Source
Device Recall
External ID
Z-1463-2023
Action Date
2023-05-03
Status
Ongoing
Category
device
Product Description
VersaOne Reusable Positioning Cannula 8 mm Standard, Model Number RC8STS
Lot/Code Info: 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
Quantity Affected: 145 units
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.
Distribution
Worldwide - US Nationwide distribution in the states of NC and the countries of Belgium, Denmark, France, Germany, India, Italy, Netherlands, Spain, Sweden.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-03-22
Company
Mansfield, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 122 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Covidien LP has 89 FDA actions in our database, including 89 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Covidien LP) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Covidien LP have FDA actions?
Covidien LP has 89 FDA actions in our database, including 89 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1463-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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