The Recall Desk
ModerateFDA (Devices)·Z-0801-2018·Announced 2018-03-07

Avid Medical Recalls TruCustom SPINE Kits Due to Foreign Material

Avid Medical is recalling 30 TruCustom SPINE convenience kits because they may contain loose polypropylene foreign material in the needles.

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 or injuries, fitting the criteria for a moderate severity score.

Plain-English summary

Avid Medical, Inc. is recalling 30 units of AVID TruCustom SPINE convenience kits, Item Code LITT016-04. The recall is due to the presence of loose polypropylene foreign material above the release specification in the BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles contained in certain kits.

The affected lots are 1211095 and 1216086, both with an expiration date of March 1, 2018. These kits were distributed in 10 states: Illinois, Kentucky, Louisiana, Massachusetts, Missouri, New York, Ohio, Texas, Virginia, and Wisconsin.

Consumers and healthcare providers should stop using the affected kits and contact Avid Medical, Inc. for further instructions or a return.

The recalled product

Product
AVID TruCustom SPINE convenience kits, Item Code: LITT016-04
Manufacturer
Avid Medical, Inc.
Affected units
30

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 (4)

  • Lot
  • Expiration Date: 1211095
  • 3/1/2018
  • 1216086

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 →