Avid Medical Recalls Unlabeled Latex-Containing Telfa Dressing Kits
Avid Medical is recalling 200 custom procedure trays that included latex-containing Telfa dressings without latex warnings. The products were distributed to Virginia and Massachusetts.
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 on common allergens). No illnesses or injuries are reported in the source text.
Plain-English summary
Avid Medical, Inc. is recalling 200 custom procedure trays (convenience kits) that included a latex-containing Telfa Non-adherent Dressing (4"x3"). The specific product involved is Catalog No. LGHM022-02, LOT# 1021706. The recall is due to the fact that these kits were not labeled as containing latex.
The recalled products were distributed to two states: Virginia and Massachusetts. The source text does not specify the exact number of kits affected within the total quantity of 200, nor does it provide specific dates of distribution or the names of the facilities where they were sold.
Consumers and healthcare facilities should check their inventory for these specific custom procedure trays. If found, they should stop using the product and contact Avid Medical, Inc. for instructions on return or disposal. Individuals with a known latex allergy should be particularly cautious when handling these items.
The recalled product
- Product
- MAMMOGRAPHY
- Manufacturer
- Avid Medical, Inc.
- Affected units
- 200
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. LGHM022-02
- LOT# 1021706
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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