Reported Dec 4, 2019 · Ongoing
PowerPort isp M.R.I. Implantable Port with Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter
Bard Peripheral Vascular 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: Bard Peripheral Vascular Inc · 1625 W 3rd St Bldg 1 · Tempe, AZ · 85281-2438
Is this the product you have?
- PowerPort isp M.R.I. Implantable Port with Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter
- Lot codes and dates
- Product Code1808060
- Device Listing NumberD004935
- UDI(01)00801741027031(17)191130(10)RECS2407
- Lot NumberRECS2407
- Amount recalled
- 900 units
Where it was sold
- Nationwide
Why it was recalled
Complaints received that products packaged with the incorrect introducer sheath size.
This product could cause temporary or reversible health problems — stop using it.
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