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).
This recall has been terminated (originally issued November 3, 2008).
- Company
- Thomas Medical Products Inc
- Recall Initiated
- September 12, 2008
- Posted
- November 3, 2008
- Terminated
- May 6, 2009
- Recall Number
- Z-0131-2009
- Quantity
- 246,585 needles
- Firm Location
- Malvern, PA
- Official Source
- View on FDA website ↗
Reason for Recall
Difficulty inserting guidewire through introducer needle. Needle hub is not tapered down to the needle cannula.
Distribution
Nationwide distribution via distributors in CA, MA, and MN.
Lot / Code Info
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.
Root Cause
Process control
Action Taken
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.