FDA Medical Device Recalls (openFDA)
Windstone Medical Packaging, Inc.: AMS 4674 Custom Pack. For use in a general clinical procedure.
- Recall number
- Z-0376-2016
- Recalling firm
- Windstone Medical Packaging, Inc.
- Product
- AMS 4674 Custom Pack. For use in a general clinical procedure.
- Status
- Terminated
- Initiated
- 2015-11-02
- Posted
- not on file
- Terminated
- 2016-08-17
- Reason
- 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
- 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 vdavis@alignedmedicalsolutions.com.
- Quantity
- 40 kits
- Distribution
- Distributed in AL and VA.
- Lot, serial or model codes
- Lot 84370, expiration date: 2/28/2017
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KDD
- Firm FEI
- 1000125955
- Firm city
- Billings
- Firm state
- MT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28