Device 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.
Z-0991-2014
Product summary
- Firm
- Biocardia, Inc.
- Event
- Event 67492
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11 units
- Official record key
device-enforcement:Z-0991-2014
Official wording
Reason: Tyvek packaging may be worn, causing loss of package integrity.
Code information: Catalog number MAP690; Lot numbers 01162 and 01186.
Distribution pattern: US Distribution including the states of FL, MA, WY. OH, MI and KS.
Derived failure modes
-
Unknown
Tyvek packaging may be worn, causing loss of package integrity.