Avid Medical Recalls TruCustom DAVINCI PACK Convenience Kits
Avid Medical is recalling 50 TruCustom DAVINCI PACK convenience kits because they may contain needles with loose polypropylene foreign material.
What this means for you
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 50 units of AVID TruCustom DAVINCI PACK convenience kits (Item Code: ADVU037-09). The recall involves specific lots with expiration dates of January 1, 2019, and February 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 and healthcare providers should stop using the affected kits and contact Avid Medical, Inc. for further instructions or a refund.
The recalled product
- Product
- AVID TruCustom DAVINCI PACK convenience kits, Item Code: ADVU037-09
- Manufacturer
- Avid Medical, Inc.
- Category
- Medical Device — Needles
- Hazard
- Affected units
- 50
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: 1205900
- 1/1/2019
- 1214034
- 2/1/2019
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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