Agency classClass IOur severity:Severe FDA (Devices)·Z-1137-2024·Announced 2024-03-06

Centurion breast biopsy kits recalled due to potential sterility issues

Medline Industries is recalling Centurion breast biopsy kits due to a potential lack of sterility in component solutions.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

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: FDA Class I classification per agency metadata requires a minimum severity score of 4. A potential sterility issue in surgical biopsy kits presents a significant risk of serious infection and complications.

Plain-English summary

Medline Industries, LP is recalling Centurion Breast Biopsy Kits (REF MNS4360) due to a potential lack of sterility in specific component solutions. The affected components are 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP, and Saline Flush Syringe. The recall affects lot numbers 2022091690, 2022112290, and 2022120990.

The affected kits were distributed nationwide throughout the United States, including Puerto Rico, as well as to Canada, the United Arab Emirates, and Panama. The total quantity recalled is 120 units.

The potential lack of sterility means the solutions used in these kits may not be adequately sterilized for safe medical use. Healthcare facilities and medical professionals who have received kits with the affected lot numbers should stop using them immediately.

Consumers and healthcare providers should contact Medline Industries for replacement kits and proper disposal instructions for the affected products.

The recalled product

Product: Centurion Kits, trays, and packs labeled as follows: BREAST BIOPSY KIT, REF MNS4360
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Category: Medical Device — Surgical Biopsy Kit
Hazard: lack-of-sterility
Affected units: 120

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 (6)

REF MNS4360
UDI/DI 10653160141716 (case)
00653160141719 (unit)
Lot Numbers: 2022091690
2022112290
2022120990

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 49 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 49 products in this recall →

Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield

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Same hazard · lack of sterility