The Recall Desk
ModerateFDA (Devices)·Z-0781-2018·Announced 2018-03-07

Avid Medical Recalls Vascular and Neuro Kits with Foreign Material

Avid Medical is recalling 200 TruCustom DJ's Vascular/Neuro Tray kits because they may contain needles with loose polypropylene foreign material.

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, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity score.

Plain-English summary

Avid Medical, Inc. is recalling 200 units of AVID TruCustom DJ'S VASCULAR/NEURO TRAY convenience kits, Item Code AV010930-12. The recall involves specific lots with expiration dates of August 1, 2019, and October 1, 2019.

The recall was initiated because certain kits contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the release specification. The agency has classified this as a Class II recall.

The affected products were distributed in 10 states: Illinois, Kentucky, Louisiana, Massachusetts, Missouri, New York, Ohio, Texas, Virginia, and Wisconsin. Consumers and healthcare providers should stop using these kits and contact Avid Medical for instructions on return or replacement.

The recalled product

Product
AVID TruCustom DJ'S VASCULAR/NEURO TRAY convenience kits, Item Code: AV010930-12
Manufacturer
Avid Medical, Inc.
Affected units
200

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
  • Expiration Date: 1205011 8/1/2019 1213805 10/1/2019

Distribution

Distributed in 10 states:

Part of a larger recall action

This product is one of 23 recalled by Avid Medical, 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 23 products in this recall →