The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0789-2018·Announced 2018-03-07

Avid Medical Recalls TruCustom Kits with Foreign Material in Needles

Avid Medical is recalling TruCustom GENERAL PACK kits because some contain needles with loose polypropylene foreign material above release specifications.

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. The hazard involves foreign material in needles, which is a quality defect, but 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 630 units of AVID TruCustom GENERAL PACK convenience kits, Item Codes LGHM041-06 and LGHM041-08. The recall involves specific lots with expiration dates of 7/1/2019, 10/1/2018, and 8/1/2017.

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 affected products were distributed in 10 states: Illinois, Kentucky, Louisiana, Massachusetts, Missouri, New York, Ohio, Texas, Virginia, and Wisconsin.

Consumers should check their inventory for the specific item codes and lot numbers listed above. If the product matches the recalled description, it should be returned to the supplier or disposed of according to local regulations.

The recalled product

Product
AVID TruCustom GENERAL PACK convenience kits, Item Code: LGHM041-06 and LGHM041-08
Manufacturer
Avid Medical, Inc.
Category
Medical Device — Syringes and Needles
Hazard
Affected units
630

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: 1213947
  • 7/1/2019
  • 1216720
  • 10/1/2018
  • 1221271
  • 8/1/2017

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 →

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