AMD-RITMED Conforming Stretch Gauze Bandages Recalled for Sterility Failure
AMD-RITMED is recalling specific lots of sterile conforming stretch gauze bandages because FDA testing showed they did not meet sterility requirements.
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. Under the severity rubric, an FDA Class II recall involving a medical device that failed sterility requirements (a significant safety defect) is categorized as Severe.
Plain-English summary
AMD-RITMED, Inc. is recalling AMD-RITMED brand Conforming Stretch Gauze Bandages, Sterile, 6 in x 4/1 yds./15 cm x 3.7 cm (Reorder Number/Code D606). The recall involves Lot 64155 with an expiration date of 2017-06. The product was manufactured in China and distributed in the United States by AMD-RITMED, Inc. in Tonawanda, NY.
The recall was initiated because the product lot did not meet sterility requirements based on FDA sampling and analysis. These bandages are intended to cover and protect wounds from further injuries and contamination in health care facilities.
A total of 107 cases (48 rolls per case) were distributed in the United States. The affected units were distributed in the states of New York, California, and Tennessee. Health care facilities should stop using the affected product and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- AMD-RITMED brand Conforming Stretch Gauze Bandages, Sterile, 6 in x 4/1 yds./15 cm x 3.7 cm, Reorder Number/Code D606, Bar code 6 86864 04230 3, Made in China -- Manufactured for & distributed by: AMD-RITMED INC. Montreal Quebec H8T 3J8 -- US Distribution: AMD-RITMED INC.…
- Manufacturer
- Amd-Ritmed, Inc.
- Category
- Medical Device — Wound Care
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 64155
- Expiration Date 2017-06
Distribution
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