The Recall Desk
ModerateFDA (Devices)·Z-0784-2018·Announced 2018-03-07

Avid Medical Recalls Heart Cath Tray Kits Due to Foreign Material

Avid Medical is recalling 354 TruCustom Heart Cath Tray kits because they may contain loose polypropylene foreign material in the included 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 hazard involves a foreign material defect in a medical device. No illnesses or injuries are reported in the source text, and the defect is a quality specification issue rather than a high-risk pathogen or structural failure.

Plain-English summary

Avid Medical, Inc. is recalling 354 units of AVID TruCustom HEART CATH TRAY convenience kits, Item Code LAKC022-06. The recall affects kits distributed in Illinois, Kentucky, Louisiana, Massachusetts, Missouri, New York, Ohio, Texas, Virginia, and Wisconsin. The affected lots have expiration dates of January 1, 2019, and October 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. This foreign material is a quality defect that does not meet the manufacturer's standards.

Healthcare facilities and consumers should stop using these specific kits and contact Avid Medical, Inc. for instructions on how to return the product or obtain a replacement.

The recalled product

Product
AVID TruCustom HEART CATH TRAY convenience kits, Item Code: LAKC022-06
Manufacturer
Avid Medical, Inc.
Affected units
354

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: 1193636
  • 1/1/2019
  • 1198134
  • 10/1/2019

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 →