The Recall Desk
ModerateFDA (Devices)·Z-0581-2018·Announced 2018-02-21

Avid Medical QA Pack Recall Due to Expired Swab Stick Component

Avid Medical is recalling 330 QA Packs because the included swab stick expires before the kit's expiration date.

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 hazard is a labeling/expiration discrepancy without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Avid Medical, Inc. is recalling 330 units of the AVID Medical QA Pack AV10654-10. The recall is being conducted because the swab stick collection device provided in the convenience kit expires prior to the kit expiration date.

The affected products were distributed to seventeen sites located in 13 states: Florida, Indiana, Kansas, Kentucky, Massachusetts, Oklahoma, North Carolina, Nebraska, New York, Ohio, Pennsylvania, Virginia, and Texas. The specific lot information includes Avid Medical Kit Lot 1235229 (expiration date 2017-08-01) and Swab Stick lots 5M03A (expiration date 2017-06-03) and 6A21A (expiration date 2017-07-21).

Consumers and healthcare facilities should stop using the affected QA Packs and contact Avid Medical, Inc. for further instructions or a replacement.

The recalled product

Product
AVID Medical QA Pack AV10654-10
Manufacturer
Avid Medical, Inc.
Affected units
330

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 (1)

  • Avid Medical Kit Lot 1235229 (expiration date 2017-08-01)

Distribution

Distributed in 13 states: