Reported May 3, 2023 · Ongoing
VersaOne Reusable Positioning Cannula 8 mm Standard, Model Number RC8STS
Covidien LP
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Covidien LP · 15 Hampshire St · Mansfield, MA · 02048-1113
Is this the product you have?
- VersaOne Reusable Positioning Cannula 8 mm Standard, Model Number RC8STS
- Lot codes and dates
- UDI-DI10884521784024
- Serial Numbers
145 of 145 codes
C21RAE0063C21RAE0064C21RAE0065C21RAE0072C21RAE0074C21RAE0032C21RAE0033C21RAE0035C21RAE0036C21RAE0037C21RAE0039C21RAE0054C21RAE0055C21RAE0062C21RAE0073C21RAE0075C21RAH0001C21RAH0002C21RAH0003C21RAH0004C21RAH0005C21RAE0051C21RAE0052C21RAE0053C21RAK0024C21RAK0025C21RAK0026C21RAE0044C21RAE0045C21RAH0012C21RAH0017C21RAH0018C21RAH0019C21RAH0020C21RAK0001C21RAK0002C21RAK0003C21RAK0004C21RAK0005C21RAK0007C21RAK0012C21RAK0013C21RAK0014C21RAH0006C21RAH0007C21RAH0008C21RAH0009C21RAH0010C21RAH0011C21RAK0006C21RAK0010C21RAK0011C21RAG0006C21RAG0007C21RAG0008C21RAG0009C21RAG0010C21RAG0011C21RAG0012C21RAG0013
- Amount recalled
- 145 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
- NC
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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