Z-2771-2024Class II

Centurion procedure kits, labeled as: 1) BREAST BIOPSY KIT, Pack Number MNS6950A; 2) BREAST BIOPSY PACK, Pack...

Name: Z-2771-2024 Centurion procedure kits, labeled as: 1) BREAST BIOPSY KIT, Pack Number MNS6950A; 2) BREAST BIOPSY PACK, Pack...
Creator: MEDLINE INDUSTRIES, LP - Northfield
Published: 2024-04-08
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2024-04-08 / Open, Classified

FDA source

MEDLINE INDUSTRIES, LP - Northfield began a recall of Centurion procedure kits, labeled as: 1) BREAST BIOPSY KIT, Pack Number MNS6950A; 2) BREAST BIOPSY PACK, Pack number BT515A on 2024-04-08. FDA classified it as Class II and gives the reason as "Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2771-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-04-08
Posted: 2024-08-28
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Centurion procedure kits, labeled as: 1) BREAST BIOPSY KIT, Pack Number MNS6950A; 2) BREAST BIOPSY PACK, Pack number BT515A
Product code: PXP Breast Biopsy / Localization Tray
Reason for recall: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
FDA root cause: Under Investigation by firm
Action: Medline Industries LP issued a recall notice to its consignees on 04/08/2024 via letter delivered via USPS and email. The notice explained the issue, provided a link to for information pertaining to the risk involved https://www.fda.gov/medical-devices/safety-communications/update-evaluating-plastic-syringes-made-china-potential-device-failures-fda-safety-communication) and request that the syringes within the convenience be discarded, except for circumstances where no alternative syringes are readily available. If these syringes must be used, closely monitor for leaks, breakage, and any other problems, and report any quality issues to Medline and the FDA. Distributors were directed to notify their customers. The firm issued a second recall notice (an expansion) on 05/02/2024 using the same methods.
Distribution: worldwide
Product codes and lots: MNS6950A, Lot Number 2018101150; MNS6950A, Lot Number 2019022550; MNS6950A, Lot Number 2019040350; BT515A, Lot Number 2020040990; BT515A, Lot Number 2021062990; BT515A, Lot Number 2022012090; BT515A, Lot Number 2022022890; BT515A, Lot Number 2022072990; BT515A, Lot Number 2022103190; BT515A, Lot Number 2023031790; BT515A, Lot Number 2023032890; BT515A, Lot Number 2023072590; BT515A, Lot Number 2024022990;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2771-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2766-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-04	2024-08-28
Z-2767-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-04	2024-08-28
Z-2768-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-04	2024-08-28
Z-2769-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-04	2024-08-28
Z-2770-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-04	2024-08-28
Z-2771-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-04	2024-08-28
Z-2772-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-04	2024-08-28
Z-2773-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-04	2024-08-28

Product code PXP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)