Recall Z-0377-2016 ยท KDD Kit, Surgical Instrument, Disposable
Windstone Medical Packaging, Inc.
AMS 4675 Angio Pack. For use in a general clinical procedure.
| Date | Nov 2, 2015 |
| Status | Terminated |
| Reason | AMS 4675 Angio 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 b |
| Quantity | 40 kits |
| Distribution | Distributed in AL and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.