Avid Medical Recalls TruCustom Electro Physiology Kits Due to Foreign Material
Avid Medical is recalling 15 TruCustom Electro Physiology PK convenience kits because they may contain loose polypropylene foreign material in the 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 source text does not report any illnesses or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
Avid Medical, Inc. is recalling 15 units of AVID TruCustom ELECTRO PHYSIOLOGY PK convenience kits, Item Code: LGHM033-04. The recall is due to the presence of loose polypropylene foreign material above the release specification in the BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles packed in certain kits.
The affected kits have lot number 1150308 and an expiration date of 1/1/2020. These products were distributed in 10 states: Illinois, Kentucky, Louisiana, Massachusetts, Missouri, New York, Ohio, Texas, Virginia, and Wisconsin.
Consumers and healthcare providers should stop using the affected kits and contact Avid Medical, Inc. for further instructions or a return.
The recalled product
- Product
- AVID TruCustom ELECTRO PHYSIOLOGY PK convenience kits, Item Code: LGHM033-04
- Manufacturer
- Avid Medical, Inc.
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 15
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 (3)
- Lot
- Expiration Date: 1150308
- 1/1/2020
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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