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U.S. Department of Health and Human Services

Class 2 Device Recall AMS 4674 Custom Pack

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  Class 2 Device Recall AMS 4674 Custom Pack see related information
Date Initiated by Firm November 02, 2015
Create Date December 04, 2015
Recall Status1 Terminated 3 on August 17, 2016
Recall Number Z-0376-2016
Recall Event ID 72604
Product Classification Kit, surgical instrument, disposable - Product Code KDD
Product AMS 4674 Custom Pack. For use in a general clinical procedure.
Code Information Lot 84370, expiration date: 2/28/2017 
Recalling Firm/
Manufacturer		 Windstone Medical Packaging, Inc.
1602 4th Ave N
Billings MT 59101-1521
For Additional Information Contact Vickie Davis
321-527-7714
Manufacturer 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.
FDA Determined
Cause 2		 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 in Commerce 40 kits
Distribution Distributed in AL and VA.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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