AMS 4674 Custom Pack. For use in a general clinical procedure.
Recall
- Recall Number
- Z-0376-2016
- Event Number
- 72604
- Firm
- Windstone Medical Packaging, Inc.
- FEI Number
- 1000125955
- Product Code
- KDD
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- November 2, 2015
- Terminated
- August 17, 2016
- Address
- 1602 4th Ave N, Billings, MT, 59101-1521
Description
AMS 4674 Custom Pack. For use in a general clinical procedure.
AMS 4674 Custom Pack is recalled because this kit containing U-SDN 2 Part Ultra Modified Seldinger Needle which is recalled by supplier.
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].
Distributed in AL and VA.
40 kits