Reported Oct 16, 2019 · Terminated
Stryker Neurovascular, Merci 9F, 80cm, Balloon Guide Catheter, REF 90077, CE 0459, UPN Product No. 90077, UDI #:…
Stryker Neurovascular
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: Stryker Neurovascular · 47900 Bayside Pkwy · Fremont, CA · 94538-6515
Is this the product you have?
Stryker NeurovascularMerci 9F80cmBalloon Guide CatheterREF 90077CE 0459UPN Product No. 90077UDI #: (01)00815742000771
- Lot codes and dates
- Lot number 0000010779; This lot was not distributed within the US
- Amount recalled
- 190 catheter guides
Why it was recalled
Labeling error; 8F Balloon Guide Catheters have been packaged within 9F Balloon Guide Catheter packaging
This product could cause temporary or reversible health problems — stop using it.
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