FDA Device recall Z-0355-2016
U-SDN 2 Part Ultra Modified Seldinger Needles, NS/37-0387
- FDA Device
- Class II
- terminated
- Published 2015-12-09
On 2015-12-09 the FDA classified a Class II recall of U-SDN 2 Part Ultra Modified Seldinger Needles, NS/37-0387 by Procedure Products, citing the firm had received a complaint alleging that a medical professional had difficulty inserting a guide wire into a needle.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0355-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-10-27 |
| Published | 2015-12-09 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Procedure Products |
| Distribution | MT, NY |
Product
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 opening in the vessel. Vessel dilator, for percutaneous catheterization.
Reason
The firm had received a complaint alleging that a medical professional had difficulty inserting a guide wire into a needle
Identifiers
| code_info | Lot 9184-A |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0355-2016%22
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