AMD-Ritmed Transparent Dressing Recalled for Sterility Failure
AMD-Ritmed is recalling Lot 68408 of transparent dressings because FDA testing found the sterile products were contaminated.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a sterile medical device that was found to be contaminated, which meets the rubric criteria for a Severe severity score.
Plain-English summary
AMD-Ritmed, Inc. is recalling Lot 68408 of AMD-Ritmed Transparent Dressing - Window with label, 4 " x 4 3/4" (10 cm x 12 cm), Reorder No./Code A60044-W. The recall involves 216 cases, with 200 dressings per case, distributed in New York, Massachusetts, Virginia, and Tennessee. The products have an expiration date of May 2018.
The recall was initiated because FDA sampling and analysis determined that the lot of transparent dressings was contaminated and not sterile. The products were manufactured in China for AMD-Ritmed, Inc.
Consumers and healthcare facilities should stop using the affected dressings and contact AMD-Ritmed, Inc. for further instructions or a return.
The recalled product
- Product
- AMD-Ritmed Transparent Dressing - Window with label, 4 " x 4 3/4" (10 cm x 12 cm), Reorder No./Code A60044-W, Sterile -- 200 Dressings per case -- Made in China for AMD-Ritmed Inc. 1200 55th Ave., Lachine, QC H8T 3J8/295 Firetower Road, Tonawanda, NY 14150
- Manufacturer
- Amd-Ritmed, Inc.
- Category
- Medical Device — Dressings
- Hazard
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)
- Lot 68408
- expiration date 2018¿05
Distribution
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