Z-0991-2014 Class II Terminated
FDA device recall Z-0991-2014 was initiated by Biocardia, Inc. on February 7, 2014 and is designated Class II. Reason for recall: Tyvek packaging may be worn, causing loss of package integrity. The recall status is terminated (terminated April 3, 2014). Affected quantity: 11 units.
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.