The Recall Desk
ModerateFDA (Devices)·Z-0788-2018·Announced 2018-03-07

Avid Medical Recalls TruCustom Extremity Pack Kits Due to Foreign Material

Avid Medical is recalling 48 TruCustom Extremity Pack 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, which typically indicates a temporary or medically reversible adverse health consequence. The hazard is a foreign material defect in a non-sterile needle, which is a quality control issue without reported injuries or deaths in the source text.

Plain-English summary

Avid Medical, Inc. is recalling 48 units of AVID TruCustom EXTREMITY PACK convenience kits, Item Codes MADN012-01 and MADN012-02. The recall involves specific lots with expiration dates of 12/1/2017 and 8/1/2019.

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

Consumers who have these specific kits should stop using them and contact Avid Medical, Inc. for further instructions or a return.

The recalled product

Product
AVID TruCustom EXTREMITY PACK convenience kits, Item Code: MADN012-01 and MADN012-02
Manufacturer
Avid Medical, Inc.
Affected units
48

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 (5)

  • Lot
  • Expiration Date: 1212610
  • 12/1/2017
  • 1218388
  • 8/1/2019

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 →