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.
This recall has been terminated (originally issued December 17, 2005).
- Company
- Thomas Medical Products Inc
- Recall Initiated
- November 7, 2005
- Posted
- December 17, 2005
- Terminated
- June 14, 2006
- Recall Number
- Z-0297-06
- Quantity
- 445 kits
- Firm Location
- Malvern, PA
- Official Source
- View on FDA website ↗
Reason for Recall
mislabeled as 9.5F actually contains 10.5F
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 / Code Info
Catalog number 808950, Lot number S16143
Root Cause
Other
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.
More recalls by Thomas Medical Products Inc
SafeSheath(R) CSG(R) Coronary Sinus guide Braided Core Hemostatic Introducer, SafeSheath(R) Worley T...
Jan 11, 2012
Thomas Medical Products, Acuity Bleed back Control Valve, Acuity Rotating Hemostasis Valve, Acuity U...
Feb 14, 2011
Thomas Medical Products, SafeSheath Long, (Tear-Away Sheath Introducer Set with Integral Hemostasis...
Feb 14, 2011