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Terminated

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.

FDA Recall Z-1228-2011 · Posted 2011-02-14

Recalling FirmThomas Medical Products Inc
Recall StatusTerminated
Product CodeDQY
Date Initiated2010-12-16
Date Terminated2012-08-08
Product Quantity28,679 for all products

Reason for Recall

Compromised sterility/weak or open seals.

Firm Action

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.

Root Cause

Packaging process control

Distribution Pattern

Distribution Nationwide USA and Germany.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K072745Y-GLIDEThomas Medical Products, Inc. · 2008-01-04K003731SAFESHEATH MSP INTRODUCER SHEATH KIT WITH INTEGRAL HEMOSTASIS VALVEThomas Medical Products, Inc. · 2001-04-10K934901TEAR-AWAY SHEATH INTRODUCER SET WITH INTEGRAL HEMOSTASIS VALVEThomas Medical Products, Inc. · 1994-01-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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