Avid Medical Recalls TruCustom PV Minor Pack Convenience Kits
Avid Medical is recalling 52 TruCustom PV Minor Pack convenience kits because they may contain needles with loose polypropylene foreign material.
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, injuries, or hospitalizations, fitting the criteria for a moderate severity score.
Plain-English summary
Avid Medical, Inc. is recalling 52 units of AVID TruCustom PV MINOR PACK convenience kits, Item Codes MADN017-02 and MADN017-03. The recall affects specific lots with expiration dates ranging from 2017 to 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 should stop using the affected kits and contact Avid Medical, Inc. for further instructions or a replacement.
The recalled product
- Product
- AVID TruCustom PV MINOR PACK convenience kits, Item Code: MADN017-02 and MADN017-03
- Manufacturer
- Avid Medical, Inc.
- Category
- Medical Device — Needles
- Hazard
- Affected units
- 52
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 (8)
- Lot
- Expiration Date: 1203390
- 9/1/2019
- 1203391
- 12/1/2017
- 1218389
- 10/1/2019
- 1218390
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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