Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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.

FDA Recall Z-1227-2011 · Posted 2011-02-14

Recalling FirmThomas Medical Products Inc
Recall StatusTerminated
Product CodeDYB
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.

K003731SAFESHEATH MSP INTRODUCER SHEATH KIT WITH INTEGRAL HEMOSTASIS VALVEThomas Medical Products, Inc. · 2001-04-10

Official Source

View FDA Recall →

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

↑