Breast biopsy kits recalled due to defective syringes with leaks and breakage
Medline Industries recalls Centurion breast biopsy procedure kits due to defective plastic syringes that may leak or break. The syringes are affected by an FDA safety alert and pose potential risks during medical procedures.
What this means for you
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 recall involving quality defects (leaks, breakage) in syringes used for invasive breast biopsy procedures. While no illnesses or injuries are reported in the source, the identified defects pose a direct risk of harm in a medical procedure context.
Plain-English summary
Medline Industries is recalling Centurion breast biopsy procedure kits (pack numbers MNS6950A and BT515A). These kits contain plastic syringes affected by an FDA safety alert issued March 19, 2024.
The syringes have quality issues including leaks, breakage, and other defects. These issues may pose a risk to patient health during breast biopsy procedures.
The affected products were distributed worldwide. Affected lot numbers span from 2018 through 2024. More information is available from the FDA and Medline Industries.
The recalled product
- Product
- Centurion procedure kits, labeled as: 1) BREAST BIOPSY KIT, Pack Number MNS6950A; 2) BREAST BIOPSY PACK, Pack number BT515A
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
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 (15)
- MNS6950A
- Lot Number 2018101150
- Lot Number 2019022550
- Lot Number 2019040350
- BT515A
- Lot Number 2020040990
- Lot Number 2021062990
- Lot Number 2022012090
- Lot Number 2022022890
- Lot Number 2022072990
- Lot Number 2022103190
- Lot Number 2023031790
- Lot Number 2023032890
- Lot Number 2023072590
- Lot Number 2024022990
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 8 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.
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