MORPH ACCESSPRO Steerable Introducer; 6F introducer, 90 cm working length: Sterile in unopened, undamaged pouch. Sterili
FDA device recall Z-0991-2014 · posted 2014-02-19 · Terminated
Recall details
- Recalling firm
- Biocardia, Inc.
- Reason for recall
- Tyvek packaging may be worn, causing loss of package integrity.
- Action taken
- Sales Representative called each affected hospital on February 7, 2014, to notify them of the recall. BioCardia has initiated a recall of Morph AccessPro due to a potential compromise of the sterile barrier. Use of this product may result in patient infection. Sales representatives contacted hospital sites identified in Attachment 3 by telephone. Script provided as follows: "BioCardia has initiated a recall of Morph Access Pro due to a potential compromise of the sterile barrier. Use of this product may result in patient infection. Our records indicate that we sold you. The recall is limited to these units in this lot sold to you. We would like to confirm if you still have the unit(s). If you do, we ask that you quarantine the unit(s) and our customer service department will contact you to coordinate the return of the unit(s)." For further questions please call (650) 226-0133.
- Root cause
- Process control
- Status
- Terminated
- Product code
- DYB
- Quantity affected
- 11 units
- Distribution
- US Distribution including the states of FL, MA, WY. OH, MI and KS.
- Date initiated
- 2014-02-07
- Date posted
- 2014-02-19
- Date terminated
- 2014-04-03
- Location
- San Carlos, CA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BIOCARDIA MORPH SHEATH GUIDE (K090999) | Biocardia, Inc. | 2009-04-15 |