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Biocardia, Inc. recalls MORPH ACCESSPRO Steerable Introducer; 6F introducer, 90 cm working length: Sterile in unopened, undamaged pouch. Steri
Recalled February 26, 2014 · FDA recall Z-0991-2014 · Biocardia
Hazard
Tyvek packaging may be worn, causing loss of package integrity. · FDA Class II
Units
11 units
Sold at
US Distribution including the states of FL, MA, WY. OH, MI and KS.
Description
Tyvek packaging may be worn, causing loss of package integrity.
Product
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.
Manufacturer(s)
Biocardia, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →