Class II — Procedure Products, Inc.
| Recalling firm | Procedure Products, Inc. |
|---|---|
| Registered facility | PROCEDURE PRODUCTS, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The firm had received a complaint alleging that a medical professional had difficulty inserting a guide wire into a needle |
| 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. |
| Quantity | 1100 pieces |
| Distribution | Distributed in the states of MT and NY. |
| Initiated | 2015-10-27 |
| Classified | 2015-12-01 |
| Terminated | 2016-04-01 |
| Recall number | Z-0355-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Procedure Products, Inc. (Z-0355-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/72596/
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