The Recall Desk
ModerateFDA (Devices)·Z-0793-2018·Announced 2018-03-07

Avid Medical Recalls TruCustom Lower Extremity Kits Due to Foreign Material

Avid Medical is recalling 120 TruCustom Lower Extremity convenience 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 hazard involves foreign material in a medical device without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Avid Medical, Inc. is recalling 120 units of AVID TruCustom LOWER EXTREMITY convenience kits, Item Codes LGHM038-03 and LGHM038-04. The recall is due to the presence of BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the release specification.

The affected kits were distributed in 10 states: Illinois, Kentucky, Louisiana, Massachusetts, Missouri, New York, Ohio, Texas, Virginia, and Wisconsin. The specific lot numbers and expiration dates are 1207468 (9/1/2019), 1216677 (9/1/2019), 1221264 (9/20/2019), and 1222553 (9/1/2019).

Consumers and healthcare facilities should stop using these kits and contact Avid Medical, Inc. for further instructions or a replacement.

The recalled product

Product
AVID TruCustom LOWER EXTREMITY convenience kits, Item Code: LGHM038-03 and LGHM038-04
Manufacturer
Avid Medical, Inc.
Affected units
120

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 (7)

  • Lot
  • Expiration Date: 1207468
  • 9/1/2019
  • 1216677
  • 1221264
  • 9/20/2019
  • 1222553

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 →