Avid Medical Recalls TruCustom NEURO Kits Due to Foreign Material
Avid Medical is recalling 46 TruCustom NEURO 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a foreign material defect that poses a risk of harm, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Avid Medical, Inc. is recalling 46 units of AVID TruCustom NEURO PK convenience kits, Item Code LGHM021-08. 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 kits are identified by Lot 1212598 and have an expiration date of 12/31/2018. 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 these kits and contact Avid Medical, Inc. for further instructions or a replacement.
The recalled product
- Product
- AVID TruCustom NEURO PK convenience kits, Item Code: LGHM021-08
- Manufacturer
- Avid Medical, Inc.
- Category
- Medical Device — Needles
- Hazard
- Affected units
- 46
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: 1212598
- 12/31/2018
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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