The Recall Desk
ModerateFDA (Devices)·Z-0377-2016·Announced 2015-12-16

Windstone AMS 4675 Angio Pack Recalled Due to Component Issue

Windstone Medical Packaging is recalling 40 kits of the AMS 4675 Angio Pack because they contain a recalled Seldinger Needle.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any injuries, illnesses, or hospitalizations, and the hazard is limited to a component recall without specific harm data.

Plain-English summary

Windstone Medical Packaging, Inc. is recalling 40 kits of the AMS 4675 Angio Pack. The recall is being conducted because the kits contain the U-SDN 2 Part Ultra Modified Seldinger Needle, which is itself subject to a recall by its supplier.

The affected product is identified as Lot 84371 with an expiration date of 2/28/2017. The kits were distributed in Alabama and Virginia for use in general clinical procedures.

Healthcare facilities and consumers should stop using the affected kits and contact Windstone Medical Packaging, Inc. for further instructions or a return.

The recalled product

Product
AMS 4675 Angio Pack. For use in a general clinical procedure.
Affected units
40

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot 84371
  • expiration date: 2/28/2017

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 2 recalled by Windstone Medical Packaging, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →