Mermaid Medical M-Biopsy Coaxial Introducer Needles Recalled for Plastic Debris
Mermaid Medical A/S is recalling M-Biopsy Coaxial Introducer Needles due to the potential for small plastic pieces to be present in the luer of the cannula.
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 a medical device with a potential for foreign material (plastic pieces) in the luer, which poses a risk of harm during use, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Mermaid Medical A/S is recalling specific lots of M-Biopsy Coaxial Introducer Needles. The recall is issued because of the potential for small plastic pieces to be present in the luer of the cannula.
The affected devices are used to obtain one or multiple core samples from soft tissue, such as the liver, kidney, prostate, or breast. The needles are intended for use in conjunction with an M-Biopsy Biopsy Needle for a Bard Magnum or Pro-Mag Biopsy Instrument. The recall involves 320 units distributed in the United States, including Florida and Puerto Rico.
Healthcare providers and consumers should stop using the affected needles and contact Mermaid Medical A/S for further instructions. The specific lot numbers involved are P000290, P000360, P000230, P000291, P000299, and P000148.
The recalled product
- Product
- Mermaid Medical M-Biopsy Coaxial Introducer Needle, Coaxial Needle for M-Biopsy 18Gx10cm-PRO-MAG, RX Only. Single packed device in a tyvek pouches. 10 single packed devices in a white carton unit box. The M-Biopsy coaxial needle is used to obtain one or multiple core samples…
- Manufacturer
- Mermaid Medical A/S
- Category
- Medical Device — Biopsy Needles
- Hazard
- Affected units
- 320
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 (5)
- Lot No: P000290
- P000360
- P000230
- P000291
- P000299
Distribution
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