Recall Z-0355-2016 ยท DRE Dilator, Vessel, For Percutaneous Catheterization
Procedure Products, Inc.
U-SDN 2 Part Ultra Modified Seldinger Needles, NS/37-0387. All needles were sold in bulk, non-sterile, and intended for further processing. Needles are packaged in zipper-bags, 300 pieces per bag, with shipment occurring in a corrugated cardboard box. Needles consist of a stainless steel cannula with a molded plastic hub. This needle is intended to be placed over the guidewire to enlarge the open
| Date | Dec 1, 2015 (initiated Oct 27, 2015) |
| Status | Terminated |
| Reason | The firm had received a complaint alleging that a medical professional had difficulty inserting a guide wire into a needle |
| Root cause | Nonconforming Material/Component |
| Action | The firm sent the Urgent Medical Device Recall letter to their consignees via email on 10/27/15. Customers with questions can call Doug Rowley at 360-693-1832 or send email to doug@procedureproducts.com |
| Quantity | 1100 pieces |
| Distribution | Distributed in the states of MT and NY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K810859 | SINGLE USE SELDINGER/COURNAND PERC. NDL Procedure Products, Inc., Apr 11, 1981 |