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Terminated

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).

FDA Recall Z-0131-2009 · Posted 2008-11-03

Recalling FirmThomas Medical Products Inc
Recall StatusTerminated
Product CodeDYB
Date Initiated2008-09-12
Date Terminated2009-05-06
Product Quantity246,585 needles

Reason for Recall

Difficulty inserting guidewire through introducer needle. Needle hub is not tapered down to the needle cannula.

Firm 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.

Root Cause

Process control

Distribution Pattern

Nationwide distribution via distributors in CA, MA, and MN.

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. · 2001-04-10K934901TEAR-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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