Z-0297-06

Bard electrophysiology SSV H. Lee 9.5F split sheath with valve and sideport. The product is packaged in...

Name: Z-0297-06 Bard electrophysiology SSV H. Lee 9.5F split sheath with valve and sideport. The product is packaged in...
Creator: Thomas Medical Products Inc
Published: 2005-11-07
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2005-11-07 / Terminated / root cause: labeling and UDI

FDA source

Thomas Medical Products Inc began a recall of 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 on 2005-11-07. The reason FDA records is "mislabeled as 9.5F actually contains 10.5F". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0297-06
Status: Terminated
Initiated: 2005-11-07
Posted: 2005-12-17
Terminated: 2006-06-14
Recalling firm: Merit Medical Systems, 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.
Product code: DYB Introducer, Catheter
Reason for recall: mislabeled as 9.5F actually contains 10.5F
Root cause tag: labeling and UDI
FDA 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 in commerce: 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.
Product codes and lots: Catalog number 808950, Lot number S16143

Product code DYB

K934901Class IITear-Away Sheath Introducer Set with Integral Hemostasis ValveThomas Medical Products, Inc. / cleared 1994-01-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)