FDA Medical Device Recalls (openFDA)
Thomas Medical Products Inc: Bard electrophysiology SSV H. Lee 9.5F split sheath with valve and sideport. The product is packaged in individual pouches and shipped 5 pouches per case.
- Recall number
- Z-0297-06
- Recalling firm
- Thomas Medical Products Inc
- Product
- Bard electrophysiology SSV H. Lee 9.5F split sheath with valve and sideport. The product is packaged in individual pouches and shipped 5 pouches per case.
- Status
- Terminated
- Initiated
- 2005-11-07
- Posted
- 2005-12-17
- Terminated
- 2006-06-14
- Reason
- mislabeled as 9.5F actually contains 10.5F
- Root cause
- Other
- Action
- 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.
- Quantity
- 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.
- Lot, serial or model codes
- Catalog number 808950, Lot number S16143
- 510(k) numbers
- ["K934901"]
- PMA numbers
- not on file
- Product code
- DYB
- Firm FEI
- 3010665433
- Firm city
- Malvern
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28