Avid Medical Recalls Vascular and Neuro Kits with Foreign Material
Avid Medical is recalling 200 TruCustom DJ's Vascular/Neuro Tray 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, injuries, or hospitalizations, fitting the criteria for a moderate severity score.
Plain-English summary
Avid Medical, Inc. is recalling 200 units of AVID TruCustom DJ'S VASCULAR/NEURO TRAY convenience kits, Item Code AV010930-12. The recall involves specific lots with expiration dates of August 1, 2019, and October 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 agency has classified this as a Class II recall.
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 these kits and contact Avid Medical for instructions on return or replacement.
The recalled product
- Product
- AVID TruCustom DJ'S VASCULAR/NEURO TRAY convenience kits, Item Code: AV010930-12
- Manufacturer
- Avid Medical, Inc.
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 200
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 (2)
- Lot
- Expiration Date: 1205011 8/1/2019 1213805 10/1/2019
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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