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.
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, 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.
- Category
- Medical Device — Catheter Kits
- Hazard
- 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
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.
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