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Terminated

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

FDA Recall Z-0376-2016 · Posted None

Recalling FirmWindstone Medical Packaging, Inc.
Recall StatusTerminated
Product CodeKDD
Date Initiated2015-11-02
Date Terminated2016-08-17
Product Quantity40 kits

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.

Firm 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].

Root Cause

Process control

Distribution Pattern

Distributed in AL and VA.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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