Recall Z-0131-2009 ยท DYB Introducer, Catheter
Thomas Medical Products Inc
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).
| Date | Nov 3, 2008 (initiated Sep 12, 2008) |
| Status | Terminated |
| Reason | Difficulty inserting guidewire through introducer needle. Needle hub is not tapered down to the needle cannula. |
| 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 | 246,585 needles |
| Distribution | Nationwide distribution via distributors in CA, MA, and MN. |
| FDA record | Open on fda.gov |