Z-0131-2009

18 gage XTW needles, sold as a component in SafeSheath Hemostatic Tear-away Introducer System with Infusion...

Name: Z-0131-2009 18 gage XTW needles, sold as a component in SafeSheath Hemostatic Tear-away Introducer System with Infusion...
Creator: Thomas Medical Products Inc
Published: 2008-09-12
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2008-09-12 / Terminated / root cause: manufacturing process

FDA source

Thomas Medical Products Inc began a recall of 18 gage XTW needles, sold as a component in SafeSheath Hemostatic Tear-away Introducer System with Infusion Side Port kits or sold Bulk Non Sterile (BNS) on 2008-09-12. The reason FDA records is "Difficulty inserting guidewire through introducer needle. Needle hub is not tapered down to the needle cannula". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0131-2009
Status: Terminated
Initiated: 2008-09-12
Posted: 2008-11-03
Terminated: 2009-05-06
Recalling firm: Merit Medical Systems, Inc.
Product: 18 gage XTW needles, sold as a component in SafeSheath Hemostatic Tear-away Introducer System with Infusion Side Port kits or sold Bulk Non Sterile (BNS).
Product code: DYB Introducer, Catheter
Reason for recall: Difficulty inserting guidewire through introducer needle. Needle hub is not tapered down to the needle cannula.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 9/11/08, Thomas Medical Products issued letters to the distributors informing them of the problem, to cease distribution and await further instructions. Additional instructions to the distributors were to notify all their account via an advisory notice and request that the user not use the needle supplied with the kit and to replace with another commercially available sterile 18 gage introducer needle.
Quantity in commerce: 246,585 needles
Distribution: Nationwide distribution via distributors in CA, MA, and MN.
Product codes and lots: Lot numbers S25589, S25590, S25756, S25769, S25787, S25909, S25910X1, S25911, S25924, S25948, S25949, S25950, S25951, S25972, S25973, S25974, S25975, S25996, S25997, S25998, S26001, S26002, S26003, S26009, S26010, S26011, S26012, S26039,S26040, S26044, S26045, S26058, S26059, S26060, S26063, S26064,S26088, S26089, S26092, S26095, S26102, S26146, S26177, S26178, S26182, S26183, S26198, S26203, S26214, S26217, S26218, S26230, and S26345.

Product code DYB

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)