FDAFDA · Food and drugs·Recall number Z-0991-2014
MORPH ACCESSPRO Steerable Introducer; 6F introducer, 90 cm working length: Sterile in unopened, undamaged pouch. Sterilized by EtO gas, Non-pyrogenic: BioCardia 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.
Published February 26, 2014 · Recall initiated: February 7, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Tyvek packaging may be worn, causing loss of package integrity.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Biocardia, Inc.
- Distributor
- US Distribution including the states of FL, MA, WY. OH, MI and KS.
- Lot
- Catalog number MAP690; Lot numbers 01162 and 01186.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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