—#141641

Product

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

FDA product code: KDD — Kit, Surgical Instrument, Disposable
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Lot 84370, expiration date: 2/28/2017

Why it was recalled

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 (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Windstone Medical Packaging, Inc.
Address: 1602 4th Ave N, Billings, Montana 59101-1521

Distribution

Distribution pattern: Distributed in AL and VA.

Timeline

Recall initiated: 2015-11-02
Terminated: 2016-08-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #141641. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.