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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
- Category
- Medical Device — Surgical Trays
- 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
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.
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