Avid Medical Recalls TruCustom Extremity Pack Kits Due to Foreign Material
Avid Medical is recalling 48 TruCustom Extremity Pack 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, which typically indicates a temporary or medically reversible adverse health consequence. The hazard is a foreign material defect in a non-sterile needle, which is a quality control issue without reported injuries or deaths in the source text.
Plain-English summary
Avid Medical, Inc. is recalling 48 units of AVID TruCustom EXTREMITY PACK convenience kits, Item Codes MADN012-01 and MADN012-02. The recall involves specific lots with expiration dates of 12/1/2017 and 8/1/2019.
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. The affected products were distributed in 10 states: Illinois, Kentucky, Louisiana, Massachusetts, Missouri, New York, Ohio, Texas, Virginia, and Wisconsin.
Consumers who have these specific kits should stop using them and contact Avid Medical, Inc. for further instructions or a return.
The recalled product
- Product
- AVID TruCustom EXTREMITY PACK convenience kits, Item Code: MADN012-01 and MADN012-02
- Manufacturer
- Avid Medical, Inc.
- Category
- Medical Device — Needles
- Hazard
- Affected units
- 48
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: 1212610
- 12/1/2017
- 1218388
- 8/1/2019
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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