Recall Z-0991-2014— Biocardia, Inc.
Class II · Terminated
Class II FDA medical device recall by Biocardia, Inc., initiated 2014-02-07, terminated 2014-04-03. It names one FDA 510(k) clearance: K090999. 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.. Reason: Tyvek packaging may be worn, causing loss of package integrity..
- Recalling firm
- Biocardia, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-02-07
- Terminated
- 2014-04-03
- Firm location
- San Carlos, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.