The Recall Desk
HighFDA (Devices)·Z-2591-2016·Announced 2016-08-24

Avid Medical Recalls Pediatric Kidney Biopsy Trays with Unlabeled Latex

Avid Medical is recalling 20 Pediatric Kidney Biopsy Trays because they contain a latex dressing that was not labeled as such.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves allergen mislabeling (latex) on a medical device, which fits the rubric criteria for High severity (allergen mislabeling/risk-of-harm products where injury has not yet been reported).

Plain-English summary

Avid Medical, Inc. is recalling 20 Pediatric Kidney Biopsy Trays (Catalog No. MCVA0091-01, LOT# 1029428). The recall was initiated because a latex-containing Telfa Non-adherent Dressing (4"x3") was included in these custom procedure trays without the packaging being labeled to indicate the presence of latex.

The recalled product was distributed to two states: Virginia and Massachusetts. The source text does not specify the number of affected patients or report any illnesses or injuries associated with the use of these trays.

Healthcare facilities that received these trays should stop using them and contact Avid Medical, Inc. for instructions on how to return the product.

The recalled product

Product
PEDIATRIC KIDNEY BIOPSY TRAY
Manufacturer
Avid Medical, Inc.
Affected units
20

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)

  • Catalog No. MCVA0091-01
  • LOT# 1029428

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 4 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.

See all 4 products in this recall →