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.
FDA Recall Z-0355-2016 · Posted 2015-12-01
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Recalling FirmProcedure Products, Inc.
Recall StatusTerminated
Product CodeDRE
Date Initiated2015-10-27
Date Terminated2016-04-01
Product Quantity1100 pieces
Reason for Recall
The firm had received a complaint alleging that a medical professional had difficulty inserting a guide wire into a needle
Firm 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 [email protected]
Root Cause
Nonconforming Material/Component
Distribution Pattern
Distributed in the states of MT and NY.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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