The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0376-2016·Announced 2015-12-16

Windstone Medical Packaging Recalls AMS 4674 Custom Pack Due to Component Issue

Windstone Medical Packaging is recalling 40 kits of the AMS 4674 Custom Pack because they contain a recalled Seldinger Needle component.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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, which typically involves a temporary or medically reversible adverse health consequence. As no specific injuries or illnesses are reported in the source text, it falls under the Moderate category.

Plain-English summary

Windstone Medical Packaging, Inc. is recalling 40 kits of the AMS 4674 Custom 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 by Lot 84370 and has 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 4674 Custom Pack. For use in a general clinical procedure.
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Kits
Hazard
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 84370
  • 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 →

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