Reported Jul 16, 2014 · Terminated
Henora REF: 70-4026-09V1 300psi I.V. Catheter Extension Set Product Usage: Catheter extension set for high pressure…
RGI Medical Manufacturing, Inc.
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: RGI Medical Manufacturing, Inc. · 4637 NW 6th St · Gainesville, FL · 32609-0701
Is this the product you have?
- Henora REF70-4026-09V1 300psi I.V
- Catheter Extension Set Product UsageCatheter extension set for high pressure procedures
- Lot codes and dates
- Lot numbers 102131 and 110531.
- Amount recalled
- 19,200 units.
Where it was sold
Why it was recalled
Problem with low adhesion of the tubing to luer connection which may lead to a separation of the extension set while in use.
This product could cause temporary or reversible health problems — stop using it.
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