Reported Feb 27, 2013 · Terminated
Vascular Solutions, SuperCross Microcatheter, Sterilized using ethylene oxide, Rx Only, Model numbers 5300 - 5307,…
Vascular Solutions, 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: Vascular Solutions, Inc. · 6464 Sycamore Ct N · Maple Grove, MN · 55369-6032
Is this the product you have?
Vascular SolutionsSuperCross MicrocatheterSterilized using ethylene oxideRx OnlyModel numbers 5300 - 5307532453255329533253365340and 5341
- Product UsageThe SuperCross catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the coronary and/or peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and to subselectively infuse/deliver diagnostic and therapeutic agents
- Lot codes and dates
82 of 82 codes
559450551750552370552761552840552954553267553647553931554269554270554413. 555958557192557824558222558894559827560215551751552371552841553090553218553434553529554029554268554271555759555953557251559570559981560253560079560080554123556182558905560114554210555991556842557253554209555223555992556536556747557124558327558991560115561206554208555490555993556674556843558018
- Amount recalled
- 4731
Where it was sold
Why it was recalled
Vascular Solutions, Inc has discovered a potential problem with a number of lots of Supercross microcatheters. A potential for surface contamination on aged catheters was observed during in-house testing.
This product could cause temporary or reversible health problems — stop using it.
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