Home / Recalls / Biocardia, Inc. / Z-0991-2014

Z-0991-2014 Class II Terminated

Recalled by Biocardia, Inc. — San Carlos, CA

Recall Details

Product Type
Devices
Report Date
February 26, 2014
Initiation Date
February 7, 2014
Termination Date
April 3, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
11 units

Product Description

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.

Reason for Recall

Tyvek packaging may be worn, causing loss of package integrity.

Distribution Pattern

US Distribution including the states of FL, MA, WY. OH, MI and KS.

Code Information

Catalog number MAP690; Lot numbers 01162 and 01186.

Other recalls by Biocardia, Inc.

  • Z-1301-2014 Class II — Morph AccessPro Steerable Introducer; 6F Introducer, 45 cm working length Sing (March 3, 2014)
  • Z-1302-2014 Class II — Morph AccessPro Steerable Introducer; 6F Introducer, 90 cm working length: S (March 3, 2014)