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.
This recall has been terminated (originally issued February 14, 2011).
- Company
- Thomas Medical Products Inc
- Recall Initiated
- December 16, 2010
- Posted
- February 14, 2011
- Terminated
- August 8, 2012
- Recall Number
- Z-1228-2011
- Quantity
- 28,679 for all products
- Firm Location
- Malvern, PA
- Official Source
- View on FDA website ↗
Reason for Recall
Compromised sterility/weak or open seals.
Distribution
Distribution Nationwide USA and Germany.
Lot / Code Info
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.
Root Cause
Packaging process control
Action Taken
GE Healthcare Thomas medical products Recall notification dated 16 December 2010 (GEHC Ref # 35003) was sent by letter via UPS Next Day Air and/or USPS certified mail.
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, Safesheath MSP Introducer Sheath Kit with Integral Hemostasis Valve for use...
Feb 14, 2011
Thomas Medical Products, SafeSheath Long, (Tear-Away Sheath Introducer Set with Integral Hemostasis...
Feb 14, 2011