Reported Feb 26, 2014 · Terminated
MORPH ACCESSPRO Steerable Introducer; 6F introducer, 90 cm working length: Sterile in unopened, undamaged pouch.…
Biocardia, 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: Biocardia, Inc. · 125 Shoreway Rd Ste B · San Carlos, CA · 94070-2718
Is this the product you have?
MORPH ACCESSPRO Steerable Introducer6F introducer90
- cm working lengthSterile in unopened, undamaged pouch. Sterilized by EtO gas
- Non-pyrogenicBioCardia Inc. San Carlos, CA 94070 Intended to provide a pathway through which medical instruments such as balloon dilation catheters, guidewires and other therapeutic devices may be introduced into the peripheral vasculature
- Lot codes and dates
Catalog number MAP690Lot numbers 01162 and 01186
- Amount recalled
- 11 units
Where it was sold
Why it was recalled
Tyvek packaging may be worn, causing loss of package integrity.
This product could cause temporary or reversible health problems — stop using it.
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