Z-1227-2011

Thomas Medical Products, Safesheath MSP Introducer Sheath Kit with Integral Hemostasis Valve for use during...

Name: Z-1227-2011 Thomas Medical Products, Safesheath MSP Introducer Sheath Kit with Integral Hemostasis Valve for use during...
Creator: Thomas Medical Products Inc
Published: 2010-12-16
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2010-12-16 / Terminated / root cause: packaging

FDA source

Thomas Medical Products Inc began a recall of Thomas Medical Products, Safesheath MSP Introducer Sheath Kit with Integral Hemostasis Valve for use during vascular interventional procedures. SafeSheath... on 2010-12-16. The reason FDA records is "Compromised sterility/weak or open seals". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1227-2011
Status: Terminated
Initiated: 2010-12-16
Posted: 2011-02-14
Terminated: 2012-08-08
Recalling firm: Merit Medical Systems, Inc.
Product: 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.
Product code: DYB Introducer, Catheter
Reason for recall: Compromised sterility/weak or open seals.
Root cause tag: packaging
FDA root cause: 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.
Product codes and lots: SafeSheath Sealing Adapter, Part No. FCL-094-03, Catalog No. SSSA-EW-09, Lot #S32071; SafeSheath Sealing Adapter, Part No. FCL-141-01, Catalog No. 369826, Lot #S32067; Transvalvular Insertion Tool (TVI), Part #MIS-099-00, Catalog No. TVI-07, Lot #S32830; Transvalvular Insertion Tool (TVI), Part #MIS-099-00, Catalog No. TVI-07, Lot #S33028; Transvalvular Insertion Tool (TVI), Part #MIS-099-00, Catalog No. TVI-07, Lot #S33050; Transvalvular Insertion Tool (TVI), Part #MIS-099-00, Catalog No. TVI-07, Lot #S33628; Transvalvular Insertion Tool (TVI), Part #MIS-122-00, Catalog No. TVI-09, Lot #S32206; and CPS SafeSheath Sealing Adapter, Part No. XD-2754-00, Catalog No. 410195, Lot No. S32546.

Product code DYB

K003731Class IISafesheath Msp Introducer Sheath Kit with Integral Hemostasis ValveThomas Medical Products, Inc. / cleared 2001-04-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)