Z-0355-2016Class II

U-SDN 2 Part Ultra Modified Seldinger Needles, NS/37-0387. All needles were sold in bulk, non-sterile, and...

Name: Z-0355-2016 U-SDN 2 Part Ultra Modified Seldinger Needles, NS/37-0387. All needles were sold in bulk, non-sterile, and...
Creator: Procedure Products, Inc.
Published: 2015-10-27
License: https://open.fda.gov/license/

Procedure Products, Inc. / initiated 2015-10-27 / Terminated / root cause: manufacturing process

FDA source

Procedure Products, Inc. began a recall of 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... on 2015-10-27. FDA classified it as Class II and gives the reason as "The firm had received a complaint alleging that a medical professional had difficulty inserting a guide wire into a needle". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0355-2016
Classification: Class II
Status: Terminated
Initiated: 2015-10-27
Posted: 2015-12-01
Terminated: 2016-04-01
Recalling firm: Procedure Products, Inc.
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.
Product code: DRE Dilator, Vessel, For Percutaneous Catheterization
Reason for recall: The firm had received a complaint alleging that a medical professional had difficulty inserting a guide wire into a needle
Root cause tag: manufacturing process
FDA 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 [email protected]
Quantity in commerce: 1100 pieces
Distribution: Distributed in the states of MT and NY.
Product codes and lots: Lot 9184-A

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0355-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0355-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-09	2015-12-01

Product code DRE

K810859Class IISingle Use Seldinger/cournand Perc. NdlProcedure Products, Inc. / cleared 1981-04-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)