Device Recall Safesheath MSP Introducer Sheath Kit with Integral Hemostasis Valve
Modelo / Serial
Contamination Sleeve part no. CON-006-02, lot no. S32943; Acuity Bleedback Control Valve part no. CSP-001-00, lot no. Z0000040; Acuity Rotating Hemostasis Valve part no. CSP-002-01, lot no. Z0000036; Acuity Universal Cutter part no. CSP-003-00, lot numbers Z0000038 and Z0000039; Acuity Universal Cutter part no. CSP-003-01, lot number Z0000054.
Thomas Medical Products, Acuity Bleed back Control Valve, Acuity Rotating Hemostasis Valve, Acuity Universal Cutter, and Contamination Sleeve for use during vascular interventional procedures. Contamination Sleeve part no. CON-006-02; Acuity Bleedback Control Valve part no. CSP-001-00; Acuity Rotating Hemostasis Valve part no. CSP-002-01; Acuity Universal Cutter part no. CSP-003-00; Acuity Universal Cutter part no. CSP-003-01.
Thomas Medical Products, Safesheath MSP Introducer Sheath Kit with Integral Hemostasis Valve for use during vascular interventional procedures. SafeSheath Sealing Adapter, Part No. FCL-094-03, Catalog No. SSSA-EW-09; SafeSheath Sealing Adapter, Part No. FCL-141-01, Catalog No. 369826; Transvalvular Insertion Tool (TVI), Part #MIS-099-00, Catalog No. TVI-07; Transvalvular Insertion Tool (TVI), Part #MIS-122-00, Catalog No. TVI-09; and CPS SafeSheath Sealing Adapter, Part No. XD-2754-00, Catalog No. 410195.