The Recall Desk
ModerateFDA (Devices)·Z-0799-2018·Announced 2018-03-07

Avid Medical Recalls TruCustom PV Minor Pack Convenience Kits

Avid Medical is recalling 52 TruCustom PV Minor Pack 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 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 52 units of AVID TruCustom PV MINOR PACK convenience kits, Item Codes MADN017-02 and MADN017-03. The recall affects specific lots with expiration dates ranging from 2017 to 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 affected products were distributed in 10 states: Illinois, Kentucky, Louisiana, Massachusetts, Missouri, New York, Ohio, Texas, Virginia, and Wisconsin.

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

The recalled product

Product
AVID TruCustom PV MINOR PACK convenience kits, Item Code: MADN017-02 and MADN017-03
Manufacturer
Avid Medical, Inc.
Affected units
52

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 (8)

  • Lot
  • Expiration Date: 1203390
  • 9/1/2019
  • 1203391
  • 12/1/2017
  • 1218389
  • 10/1/2019
  • 1218390

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 →