Remington Medical Recalls Sterile Prostate Biopsy Needles Due to Sterility Concerns
Remington Medical Inc. is recalling 800 sterile automatic cutting needles for prostate biopsies because the product's sterility may be compromised.
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. According to the rubric, an FDA Class II recall involving a medical device with a potential sterility compromise (risk of infection) falls under the 'Severe' category, as it represents a significant risk of harm even without reported injuries.
Plain-English summary
Remington Medical Inc. is recalling 800 units of Automatic Cutting Needles, Soft Tissue Biopsy Needle, model NAC-1820M, Lot 121003. The recall is being conducted because the sterility of the product may be compromised.
These sterile needles are intended for single use by a urologist in a healthcare setting to obtain needle biopsies of the prostate. The needles are compatible with the Bard Magnum biopsy instrument and feature an echogenic tip for ultrasound guidance. The affected units were distributed nationwide in the United States, including the states of Alabama, Arizona, California, Florida, Indiana, Massachusetts, North Carolina, New York, Ohio, Pennsylvania, and Texas.
Healthcare facilities and users should stop using the affected needles immediately and contact Remington Medical Inc. for instructions on return or disposal.
The recalled product
- Product
- Automatic Cutting Needles, Soft Tissue Biopsy Needle, NAC-1820M, Sterile, Remington Medical, Inc., 5830 Meadowridge Court, Alpharetta, GA 30005. Prostate Biopsy Needles shall be single use only and are to be used by a Urologist in a healthcare setting to obtain needle…
- Manufacturer
- Remington Medical Inc.
- Category
- Medical Device — Biopsy Needles
- Affected units
- 800
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)
- NAC-1820M
- Lot number: 121003
Distribution
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