Z-0376-2016Class II

AMS 4674 Custom Pack. For use in a general clinical procedure

Name: Z-0376-2016 AMS 4674 Custom Pack. For use in a general clinical procedure
Creator: Windstone Medical Packaging, Inc.
Published: 2015-11-02
License: https://open.fda.gov/license/

Windstone Medical Packaging, Inc. / initiated 2015-11-02 / Terminated / root cause: manufacturing process

FDA source

Windstone Medical Packaging, Inc. began a recall of AMS 4674 Custom Pack. For use in a general clinical procedure on 2015-11-02. FDA classified it as Class II and gives the reason as "AMS 4674 Custom Pack is recalled because this kit containing U-SDN 2 Part Ultra Modified Seldinger Needle which is recalled by supplier". 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-0376-2016
Classification: Class II
Status: Terminated
Initiated: 2015-11-02
Posted: 2015-12-04
Terminated: 2016-08-17
Recalling firm: Windstone Medical Packaging, Inc.
Product: AMS 4674 Custom Pack. For use in a general clinical procedure.
Product code: KDD Kit, Surgical Instrument, Disposable
Reason for recall: AMS 4674 Custom Pack is recalled because this kit containing U-SDN 2 Part Ultra Modified Seldinger Needle which is recalled by supplier.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Aligned Medical Solutions (AMS) sent the Procedure Products -Urgent Medical Device Recall Letter, dated November 02, 2015 to consignees. This letter listed the items affected by recall as: AMS 4674 Custom Pack and AMS 4675 Angio Pack. Both direct account and sub account are informed that the part # NS/37 -0387 01 U-SDN 2 Part Ultra Modified Seldinger Needle (introducer needle) is recalled because some was unable to accept guide wires up to .038" as intended. The inner diameter was found to be out of specification in some cases. All other components in these two AMS kits are not affected by this recall. Customers with questions about this recall can call Vicki Davis at 321-527-7714 or send email to [email protected].
Quantity in commerce: 40 kits
Distribution: Distributed in AL and VA.
Product codes and lots: Lot 84370, expiration date: 2/28/2017

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0376-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0376-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-16	2015-12-04
Z-0377-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-16	2015-12-04

Product code KDD

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)