Summary
The FDA issued a Class II for VersaOne Reusable Positioning Cannula 11mm Standard, Model Number RC11STS 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-1464-2023
Action Date
2023-05-03
Status
Ongoing
Category
device
Product Description
VersaOne Reusable Positioning Cannula 11mm Standard, Model Number RC11STS
Lot/Code Info: UDI-DI: 10884521784048; Serial Numbers: C20RSL0083 C20RSL0085 C20RSL0086 C20RSL0087 C20RSL0088 C20RSL0062 C20RSL0063 C20RSL0071 C20RSL0072 C20RSL0073 C20RSL0074 C20RSL0075 C20RSL0076 C20RSL0070 C21RSJ0012 C20RSL0066 C20RSL0080 C20RSL0095 C20RSL0098 C20RSL0077 C20RSL0078 C20RSL0097 C20RSJ0002 C20RSJ0003 C20RSJ0004 C21RSJ0001 C21RSJ0002 C21RSJ0003 C21RSJ0004 C21RSJ0005 C21RSJ0006 C21RSJ0009 C21RSJ0010 C21RSJ0011 C21RSJ0018 C21RSJ0019 C21RSJ0020 C21RSJ0021 C21RSJ0022 C21RSK0026 C21RSK0027 C21RSK0028 C21RSJ0030 C21RSK0001 C21RSK0002 C21RSJ0013 C21RSJ0014 C21RSJ0015 C21RSJ0016 C21RSK0015 C21RSK0025
Quantity Affected: 51 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-1464-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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