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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Thomas Medical Products Inc
Lot Codes / Batch Numbers
Catalog number 808950, Lot number S16143
Products Sold
Catalog number 808950, Lot number S16143
Thomas Medical Products Inc is recalling Bard electrophysiology SSV H. Lee 9.5F split sheath with valve and sideport. The product is packaged due to mislabeled as 9.5F actually contains 10.5F. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
mislabeled as 9.5F actually contains 10.5F
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, CO, IL, IN, KY, MA, MS, MO, NE, NY, NC, OH, PA, SC, TX
Page updated: Jan 10, 2026