Bard electrophysiology SSV H. Lee 9.5F split sheath with valve and sideport. The product is packaged in individual pouch
FDA device recall Z-0297-06 · posted 2005-12-17 · Terminated
Recall details
- Recalling firm
- Thomas Medical Products Inc
- Reason for recall
- mislabeled as 9.5F actually contains 10.5F
- Action taken
- The recalling firm issued letters to their direct accounts via fax on 11/7/05. Letters to the hospital accounts were mailed via UPS overnight on 11/14/05.
- Root cause
- Other
- Status
- Terminated
- Product code
- DYB
- Quantity affected
- 445 kits
- Distribution
- The products were shipped to one distributor in CA and the label holder in MA. The products were further distributed to hospitals in CA, CO, IL, KY, MO, MS, NC, NE, NY, OH, PA, SC, and TX.
- Date initiated
- 2005-11-07
- Date posted
- 2005-12-17
- Date terminated
- 2006-06-14
- Location
- Malvern, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TEAR-AWAY SHEATH INTRODUCER SET WITH INTEGRAL HEMOSTASIS VALVE (K934901) | Thomas Medical Products, Inc. | 1994-01-21 |