Reported Feb 3, 2021 · Terminated
Cardiovascular Reprocessed ViewFlex Xtra ICE Catheter, REF D087031, OM St. Jude Medical, Size 9F (3.2mm), Length 90 cm,…
Stryker Sustainability Solutions
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 Sustainability Solutions · 1810 W Drake Dr · Tempe, AZ · 85283-4327
Is this the product you have?
- Cardiovascular Reprocessed ViewFlex Xtra ICE Catheter, REF D087031, OM St. Jude Medical, Size 9F (3.2mm), Length 90 cm, Sterile EO, Rx Only, Quantity 1
- UDI07613327376067
- Lot codes and dates
101 of 101 codes
219747522354482235454224362322619032264435226446822644782264484203931420796922120924212121622649532264955226498322727872275104207311920808532081724208199220819932082097261175326524542663966266397126639562663959266397326639972663999266400026640272664028266403826640392664041266404226640542649640264964326520502652100265210626521082652123265212726521282652130265213126521752663895266390426639052663907266390926639292652008
- Amount recalled
- 101 units
Where it was sold
Why it was recalled
A subset of temporary intracardiac ultrasound catheters are labeled with the incorrect expiration date. They are mislabeled as having a shelf life of two years, while the actual shelf life is one year. The earliest affected product will expire in May 2020. Use of mislabeled devices may lead to hazards sterility breach, component breakdown or delay in treatment.
This product could cause temporary or reversible health problems — stop using it.
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