medical Class II Updated 2024-10-02

Bard Peripheral Vascular Inc recalls BARD MAGNUM Disposable Core Tissue Biopsy Needle REF: MN141

Recalled 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 and various soft tissue tumors.

Hazard / Issue

Due to possible packaging damage (indentations/cuts) cause by manufacturing process. As a result of the packaging damage, may cause the sterile barrier to be compromised.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Product Name: Magnum 14g x 10cm Catalog Number: MN1410 Lot Numbers / UDI code: REJP3295 / (01)00801741084249(17)270131(10)REJP3295 REJP2228 / (01)00801741084249(17)270131(10)REJP2228 REJN2583 / (01)00801741084249(17)261231(10)REJN2583 REJQ2851 / (01)00801741084249(17)270228(10)REJQ2851 REJQ0831 / (01)00801741084249(17)270228(10)REJQ0831 Product Name: Magnum 14g x 20cm Catalog Number: MN1420 Lot Numbers / UDI code: REHX2867 / (01)00801741084270(17)260930(10)REHX2867 Product Name: Magnum 16g x 10cm Catalog Number: MN1610 Lot Numbers / UDI code: REJN0587 / (01)00801741084287(17)261231(10)REJN0587 Product Name: Magnum 16g x 16cm Catalog Number: MN1616 Lot Numbers / UDI code: REJP3289 / (01)00801741084300(17)270131(10)REJP3289 Product Name: Magnum 18g x 20cm Catalog Number: MN1820 Lot Numbers / UDI code: REJS1418 / (01)00801741084355(17)270430(10)REJS1418 Product Name: Magnum 20g x 10cm Catalog Number: MN2010 Lot Numbers / UDI code: REJQ1160 / (01)00801741084386(17)270228(10)REJQ1160
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