BARD MAGNUM Biopsy Needles Recalled Due to Packaging Damage Risk
Bard Peripheral Vascular is recalling BARD MAGNUM Disposable Core Tissue Biopsy Needles due to possible packaging damage from manufacturing that may compromise sterility.
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: FDA Class II medical device with risk of sterile barrier compromise in a diagnostic instrument. No illnesses or injuries have been reported, making the hazard theoretical rather than confirmed, which limits the score to 3 per the rubric.
Plain-English summary
Bard Peripheral Vascular Inc. is recalling BARD MAGNUM Disposable Core Tissue Biopsy Needles (catalog numbers MN1410, MN1420, MN1610, MN1616, MN1820, and MN2010). These needles are used to obtain tissue samples from soft tissues including liver, kidney, prostate, breast, spleen, lymph nodes, and various soft tissue tumors.
The recall was initiated due to possible packaging damage—specifically indentations and cuts—that may have occurred during the manufacturing process. This packaging damage may compromise the sterile barrier that protects the needles.
Approximately 60 units were distributed in the U.S., and 5,160 units were distributed internationally in Canada, Pakistan, Peru, India, Malaysia, China, Brazil, Mexico, Japan, Chile, and Australia. Affected lot numbers include REJP3295, REJP2228, REJN2583, REJQ2851, REJQ0831, REHX2867, REJN0587, REJP3289, REJS1418, and REJQ1160.
Patients and healthcare providers who have these needles in their possession should stop using affected lots immediately. Healthcare facilities should quarantine and return affected inventory to Bard Peripheral Vascular Inc.
The recalled product
- Product
- BARD MAGNUM Disposable Core Tissue Biopsy Needle REF: MN1410 MN 1420 MN1610 MN1616 MN1820 MN2010 The Magnum Biopsy System (instrument and needles) is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, breast, spleen, lymph nodes…
- Manufacturer
- Bard Peripheral Vascular Inc
Distribution
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