The Recall Desk
ModerateFDA (Devices)·Z-1865-2017·Announced 2017-04-26

Avid Medical Recalls Vacutainer Tubes Due to Mixed Component Lots

Avid Medical is recalling 25,308 Vacutainer tubes because an expired component was found in a kit with a later expiration date, leading to incorrect lot and expiration labeling.

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, but the source text describes a labeling and inventory control error (mixed lots/incorrect expiration) without reporting any illnesses, injuries, or adverse health consequences, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Avid Medical, Inc. is recalling 25,308 units of Vacutainer tubes. These tubes are intended for clinical laboratory hematology studies, including lead level testing, FEP level testing, and CBC testing. The recall was initiated after an end-user complaint reported that a specific vacutainer component (519700) with an expiration date of 12/16 was found inside a kit labeled with an expiration date after 12/16.

An internal investigation and root cause analysis determined that mixed component lots were contained in the product 519700 component case. This error resulted in incorrect lot numbers and expiration dates being attributed to all work orders produced using the affected component. The issue was immediately contained and corrected, and a full inventory analysis confirmed that the issue affected a total of five vacutainer components.

All affected products were distributed through distribution centers confined to the US, and all end-users are located solely in the US. The recall covers specific part numbers listed in the agency documentation. Users should check their inventory against the provided part numbers and stop using any affected units.

The recalled product

Product
Vacutainer Tubes Vacutainer tubes are intended for clinical laboratory hematology studies including but not limited to lead level testing, FEP level testing, and CBC testing.
Manufacturer
Avid Medical, Inc.
Affected units
25,308

Distribution

Distribution scope not specified by the agency.