PlainRecalls
CriticalClass IOngoing

FDA Devices recall · Reported March 6, 2024

Centurion Kits, trays, and packs labeled as follows: a) A C DAILY WET KIT, REF DM405A; b) BWH DAILY DRIVELINE MGMT KIT, REF DM640; c) DAILY DRIVELINE MGMT SYSTEM, REF DM600; d) DAILY MAINTENANCE SYSTEM LVAD, REF DM870A; e) DAILY MAINTENANCE SYSTEM LVAD, REF DM870A; f) DRESSING CHANGE TRAY WITHOUT DRESSING, REF DT21465B; g) DRIVELINE MANAGEMENT SYSTEM, REF DT18905; h) DRIVELINE MANAGEMENT SYSTEM-DAILY, REF DM610; i) DRIVELINE MGMT TRAY W/O ANCHOR, REF DT18210; j) DRIVELINE MG

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, Steril…

Recall #
Z-1136-2024
Affected scope
113249 units
Initiated
November 15, 2023
Compiled from official public sources by the publisher.
Verify with FDA Devices →
View my saved recalls

Medline Industries, LP - Northfield recalled Centurion Kits, trays, and packs labeled as follows: a) A C DAILY WET KIT, REF DM405A;… - a critical-severity action.

Centurion Kits, trays, and packs labeled as follows: a) A C DAILY WET KIT, REF DM405A;… was recalled by Medline Industries, LP - Northfield in March 6, 2024. Reason: Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurs…. Check the official notice for the remedy. Verify recall #Z-1136-2024 with the FDA Devices before acting.

The recall

Medline Industries, LP - Northfield issued this critical-severity FDA Devices recall-Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurs….

Critical
severity level
113K units
affected scope
Class I
classification
March 6, 2024
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-1136-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope (see the Recall Profile below) is large enough to require multi-state distribution tracking. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Medical Devices recalls over time

Where this recall sits in its category - 41,021 medical devices recalls on record

01,0002,0003,0004,000 20052008201120142017202020232026 1,947
Severity1906864652High severity (most serious)Moderate severityLow severity
Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified high severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

Centurion Kits, trays, and packs labeled as follows: a) A C DAILY WET KIT, REF DM405A; b) BWH DAILY DRIVELINE MGMT KIT, REF DM640; c) DAILY DRIVELINE MGMT SYSTEM, REF DM600; d) DAILY MAINTENANCE SYSTEM LVAD, REF DM870A; e) DAILY MAINTENANCE SYSTEM LVAD, REF DM870A; f) DRESSING CHANGE TRAY WITHOUT DRESSING, REF DT21465B; g) DRIVELINE MANAGEMENT SYSTEM, REF DT18905; h) DRIVELINE MANAGEMENT SYSTEM-DAILY, REF DM610; i) DRIVELINE MGMT TRAY W/O ANCHOR, REF DT18210; j) DRIVELINE MGMT. KIT WITH SILVER ALGINATE, REF DT18695A; k) LVAD DAILY PATIENT CHANGE KIT, REF DM630; l) LVAD DAILY PATIENT CHANGE KIT, REF DM630; m) LVAD DRIVELINE MGMT KIT, SENSITIVE SKIN, REF DT19005A; n) LVAD MAINTENANCE KIT - LESS THAN 6 MOS., REF DM1060; o) LVAD SENSITIVE KIT, REF DM525A; p) MMC DAILY DRIVELINE MGMT KIT, REF DM850; q) PATIENT DRESSING CHANGE KIT SW, REF DT17355; r) PEDIATRIC PORT ACCESS BUNDLE, REF DT19835B; s) PORT ACCESS KIT, REF DT22575A; t) PORT ACCESS TRAY, REF DT20845B; u) PORT DRESSING CHANGE TRAY, REF DT20885B; v) PORT DRESSING CHANGE KIT, REF DT21585B; w) PORT DRESSING CHANGE KIT, REF DYNDC2815A; x) PORT KIT, REF DT22270A; y) UOU LVAD DRIVELINE MGMT COMPLICATIONS, REF DM330A; z) UOU LVAD DRIVELINE MGMT COMPLICATIONS, REF DM330A; aa) VAD DRESSING CHANGE TRAY, REF DM875; bb) VAD DRESSING CHANGE TRAY, REF DM875; cc) VAD DRIVELINE MANAGEMENT KIT HW, REF DM1105

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.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Critical (Class I)
Status Ongoing
Recall number Z-1136-2024
Date reported March 6, 2024
Date initiated November 15, 2023
Recalling firm Medline Industries, LP - Northfield
Firm location Northfield, IL
Affected scope 113249 units
Distribution Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

113249 units units affected - multi-state distribution scale.

Regional (<10K units) -
Multi-state (10K – 100K units) -
Large-scale (100K – 1M units) ✓ This recall
Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

  • Check the recall number (Z-1136-2024) and product description against the item you own. Search the archive
  • Confirm the current status with FDA Devices before acting, recall details can be updated.
  • This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼
Centurion Kits, trays, and packs labeled as follows: a) A C DAILY WET KIT, REF DM405A; b) BWH DAILY DRIVELINE MGMT KIT, REF DM640; c) DAILY DRIVELINE MGMT SYSTEM, REF DM600; d) DAILY MAINTENANCE SYSTEM LVAD, REF DM870A; e) DAILY MAINTENANCE SYSTEM LVAD, REF DM870A; f) DRESSING CHANGE TRAY WITHOUT DRESSING, REF DT21465B; g) DRIVELINE MANAGEMENT SYSTEM, REF DT18905; h) DRIVELINE MANAGEMENT SYSTEM-DAILY, REF DM610; i) DRIVELINE MGMT TRAY W/O ANCHOR, REF DT18210; j) DRIVELINE MGMT. KIT WITH SILVER ALGINATE, REF DT18695A; k) LVAD DAILY PATIENT CHANGE KIT, REF DM630; l) LVAD DAILY PATIENT CHANGE KIT, REF DM630; m) LVAD DRIVELINE MGMT KIT, SENSITIVE SKIN, REF DT19005A; n) LVAD MAINTENANCE KIT - LESS THAN 6 MOS., REF DM1060; o) LVAD SENSITIVE KIT, REF DM525A; p) MMC DAILY DRIVELINE MGMT KIT, REF DM850; q) PATIENT DRESSING CHANGE KIT SW, REF DT17355; r) PEDIATRIC PORT ACCESS BUNDLE, REF DT19835B; s) PORT ACCESS KIT, REF DT22575A; t) PORT ACCESS TRAY, REF DT20845B; u) PORT DRESSING CHANGE TRAY, REF DT20885B; v) PORT DRESSING CHANGE KIT, REF DT21585B; w) PORT DRESSING CHANGE KIT, REF DYNDC2815A; x) PORT KIT, REF DT22270A; y) UOU LVAD DRIVELINE MGMT COMPLICATIONS, REF DM330A; z) UOU LVAD DRIVELINE MGMT COMPLICATIONS, REF DM330A; aa) VAD DRESSING CHANGE TRAY, REF DM875; bb) VAD DRESSING CHANGE TRAY, REF DM875; cc) VAD DRIVELINE MANAGEMENT KIT HW, REF DM1105. Recalled by Medline Industries, LP - Northfield. Units affected: 113249 units.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on March 6, 2024. Severity: Critical. Recall number: Z-1136-2024.
Where was the recalled product distributed? ▼
Distribution: Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Similar severity · nearest report date

Same archive severity grade (Critical), closest by report date among other firms and states.

ELV ALIPOTEC brand MEXICAN TEJOCOTE ROOT … 2024-03-06 Rojo Black Bean 6 Layer Dip packaged in 2… 2024-03-06 Marketside Southwest Chopped Kit 10.3 oz.… 2024-03-06 Marketside Bacon Ranch Crunch Kit 9.8 oz.… 2024-03-06

Similar Medical Devices · nearest report date

Same product category, closest by report date among other firms and states (deduped against the severity set).

VOCSN Patient Breathing Package (Pediatri… 2024-03-06 Medtronic Duet External Drainage and Moni… 2024-03-06 Medtronic Duet External Drainage and Moni… 2024-03-06 Medtronic Duet External Drainage and Moni… 2024-03-06

Compare this recall with GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VS… → · All Medical Devices recalls

This recall: FDA Devices, reported March 6, 2024. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026