Avid Medical Recalls TruCustom Kits with Foreign Material in Needles
Avid Medical is recalling TruCustom GENERAL PACK kits because some contain needles with loose polypropylene foreign material above release specifications.
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. The hazard involves foreign material in needles, which is a quality defect, but 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 630 units of AVID TruCustom GENERAL PACK convenience kits, Item Codes LGHM041-06 and LGHM041-08. The recall involves specific lots with expiration dates of 7/1/2019, 10/1/2018, and 8/1/2017.
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 check their inventory for the specific item codes and lot numbers listed above. If the product matches the recalled description, it should be returned to the supplier or disposed of according to local regulations.
The recalled product
- Product
- AVID TruCustom GENERAL PACK convenience kits, Item Code: LGHM041-06 and LGHM041-08
- Manufacturer
- Avid Medical, Inc.
- Hazard
- Affected units
- 630
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 (7)
- Lot
- Expiration Date: 1213947
- 7/1/2019
- 1216720
- 10/1/2018
- 1221271
- 8/1/2017
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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