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U.S. Department of Health and Human Services

Class 2 Device Recall Safesheath MSP Introducer Sheath Kit with Integral Hemostasis Valve

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  Class 2 Device Recall Safesheath MSP Introducer Sheath Kit with Integral Hemostasis Valve see related information
Date Initiated by Firm December 16, 2010
Date Posted February 14, 2011
Recall Status1 Terminated 3 on August 08, 2012
Recall Number Z-1228-2011
Recall Event ID 57679
510(K)Number K072745  K934901  K003731  
Product Classification vascular interventional device - Product Code DQY
Product 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.
Code Information 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.
Recalling Firm/
Manufacturer		 Thomas Medical Products Inc
65 Great Valley Pkwy
Malvern PA 19355-1302
For Additional Information Contact Tim Stoudt
610-651-5054
Manufacturer Reason
for Recall		 Compromised sterility/weak or open seals.
FDA Determined
Cause 2		 Packaging process control
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.
Quantity in Commerce 28,679 for all products
Distribution Distribution Nationwide USA and Germany.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DQY and Original Applicant = THOMAS MEDICAL PRODUCTS, INC.
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