CLASS I ONGOING Device recall · Reported 6 Mar 2024 · FDA Enforcement Report

Centurion Kits, trays, and packs labeled as follows recalled

Medline Industries LP - Northfield is recalling Centurion Kits, trays, and packs labeled as follows: Breast Biopsy Kit, distributed nationwide in the US. The recall was initiated on 15 Nov 2023 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesREF MNS4360, UDI/DI 10653160141716 (case), 00653160141719 (unit), Lot Numbers: 2022091690, 2022112290, 2022120990
Quantity recalled120 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-1137-2024
FDA event ID
93800
Recalling firm
Medline Industries LP - Northfield, Northfield, IL
Classification
Class I
Status
Ongoing
Recall initiated
15 Nov 2023
FDA classified
24 Feb 2024
Reported
6 Mar 2024
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Sterility

Timeline

15 Nov 2023Recall initiated by company
24 Feb 2024Classified by FDA+101 days
6 Mar 2024Published in enforcement report+11 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Centurion Kits, trays, and packs labeled as follows: BREAST BIOPSY KIT, REF MNS4360

Where it was distributed

Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.

Which lots are affected?

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

Where was it sold?

Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

48 other products · FDA event 93800

This product is part of a recall event; the main page for the event is Medline Tray Trach Basic Solution recalled by MEDLINE INDUSTRIES, LP.

ReportedClassRecallCompanyReasonWhere
CLASS IMedline Tray Trach Basic Solution recalled by MEDLINE INDUSTRIES, LPMedline Industries LP - NorthfieldSterilityNationwide
CLASS IMedline Kits, trays, and packs labeled as follows: C-section recalledMedline Industries LP - NorthfieldSterilityNationwide
CLASS IMedline Kits, trays, and packs labeled as follows recalledMedline Industries LP - NorthfieldSterilityNationwide
CLASS ICenturion Kits, trays, and packs labeled as follows recalledMedline Industries LP - NorthfieldSterilityNationwide
CLASS IMedline Kits, trays, and packs labeled as follows recalledMedline Industries LP - NorthfieldSterilityNationwide
CLASS IMedline Kits, trays, and packs labeled as follows recalledMedline Industries LP - NorthfieldSterilityNationwide
CLASS IMedline Kits, trays, and packs labeled as follows: a) L&B Cds-lf recalledMedline Industries LP - NorthfieldSterilityNationwide
CLASS IMedline Kits, trays, and packs labeled as follows: a) C L PREP recalledMedline Industries LP - NorthfieldSterilityNationwide
CLASS IMedline Kits, trays, and packs labeled as follows recalledMedline Industries LP - NorthfieldSterilityNationwide
CLASS IMedline Kits, trays, and packs labeled as follows recalledMedline Industries LP - NorthfieldSterilityNationwide
CLASS IMedline Kits, trays, and packs labeled as follows recalledMedline Industries LP - NorthfieldSterilityNationwide
CLASS IMedline Kits, trays, and packs labeled as follows: a) Trach Care Kit recalledMedline Industries LP - NorthfieldSterilityNationwide
CLASS IMedline Kits, trays, and packs labeled as follows recalledMedline Industries LP - NorthfieldSterilityNationwide
CLASS IMedline Kits, trays, and packs labeled as follows recalledMedline Industries LP - NorthfieldSterilityNationwide
CLASS IMedline Kits, trays, and packs labeled as follows recalledMedline Industries LP - NorthfieldSterilityNationwide
CLASS IMedline Kits, trays, and packs labeled as follows recalledMedline Industries LP - NorthfieldSterilityNationwide
CLASS ICenturion Kits, trays, and packs labeled as follows recalledMedline Industries LP - NorthfieldSterilityNationwide
CLASS IMedline Kits, trays, and packs labeled as follows: a) Endo Kit recalledMedline Industries LP - NorthfieldSterilityNationwide
CLASS IMedline Kits, trays, and packs labeled as follows: a) Blood Draw Kit recalledMedline Industries LP - NorthfieldSterilityNationwide
CLASS IMedline Kits, trays, and packs labeled as follows: a) Cataract Pack recalledMedline Industries LP - NorthfieldSterilityNationwide
CLASS IMedline Kits, trays, and packs labeled as follows recalledMedline Industries LP - NorthfieldSterilityNationwide
CLASS IMedline Kits, trays, and packs labeled as follows: a) C-section recalledMedline Industries LP - NorthfieldSterilityNationwide
CLASS IMedline Kits, trays, and packs labeled as follows: a) Laceration KIT recalledMedline Industries LP - NorthfieldSterilityNationwide
CLASS IMedline Kits, trays, and packs labeled as follows recalledMedline Industries LP - NorthfieldSterilityNationwide
CLASS ICenturion Kits, trays, and packs labeled as follows recalledMedline Industries LP - NorthfieldSterilityNationwide
CLASS IMedline Tray care and cleaning kits and trays recalledMedline Industries LP - NorthfieldSterilityNationwide
CLASS IMedline Kits, trays, and packs labeled as follows: Serum Tear Kit recalledMedline Industries LP - NorthfieldSterilityNationwide
CLASS IMedline Kits, trays, and packs labeled as follows recalledMedline Industries LP - NorthfieldSterilityNationwide
CLASS IMedline Kits, trays, and packs labeled as follows: a) NUR recalledMedline Industries LP - NorthfieldSterilityNationwide
CLASS ICenturion Kits, trays, and packs labeled as follows: EYE PREP KIT recalledMedline Industries LP - NorthfieldSterilityNationwide
CLASS ICenturion Kits, trays, and packs labeled as follows recalledMedline Industries LP - NorthfieldSterilityNationwide
CLASS IMedline Kits, trays, and packs labeled as follows recalledMedline Industries LP - NorthfieldSterilityNationwide
CLASS ICenturion Kits, trays, and packs labeled as follows recalledMedline Industries LP - NorthfieldSterilityNationwide
CLASS IMedline Kits, trays, and packs labeled as follows recalledMedline Industries LP - NorthfieldSterilityNationwide
CLASS ICenturion Kits, trays, and packs labeled as follows recalledMedline Industries LP - NorthfieldSterilityNationwide
CLASS IMedline Kits, trays, and packs labeled as follows: a) D&C CDS recalledMedline Industries LP - NorthfieldSterilityNationwide
CLASS IMedline Kits, trays, and packs labeled as follows recalledMedline Industries LP - NorthfieldSterilityNationwide
CLASS ICenturion Kits, trays, and packs labeled as follows recalledMedline Industries LP - NorthfieldSterilityNationwide
CLASS IMedline Kits, trays, and packs labeled as follows: a) Anterior Pack recalledMedline Industries LP - NorthfieldSterilityNationwide
CLASS ICenturion Kits, trays, and packs labeled as follows recalledMedline Industries LP - NorthfieldSterilityNationwide
CLASS IMedline Kits, trays, and packs labeled as follows: a) Cath Lab Cds recalledMedline Industries LP - NorthfieldSterilityNationwide
CLASS ICenturion Kits, trays, and packs labeled as follows recalledMedline Industries LP - NorthfieldSterilityNationwide
CLASS IMedline Bronchoscopy Tray recalled by MEDLINE INDUSTRIES, LPMedline Industries LP - NorthfieldSterilityNationwide
CLASS IMedline Arterial Bundle No Catheter recalled by MEDLINE INDUSTRIES, LPMedline Industries LP - NorthfieldSterilityNationwide
CLASS IMedline kits and trays, labeled as: a) Suction Cath Kit W/Saline recalledMedline Industries LP - NorthfieldSterilityNationwide
CLASS IMedline Kits, trays, and packs labeled as follows: a) Description recalledMedline Industries LP - NorthfieldSterilityNationwide
CLASS IMedline Kits, trays, and packs labeled as follows: a) Breast Pack recalledMedline Industries LP - NorthfieldSterilityNationwide
CLASS ICenturion Kits, trays, and packs labeled as follows: Laceration Tray recalledMedline Industries LP - NorthfieldSterilityNationwide

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