Class I FDA device recall · Z-1136-2024

Class I — the FDA judged there is a reasonable probability that use of the product would cause serious harm or death.

This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone.

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

Why it was 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.

Is your unit affected?

The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.

A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.

Show the FDA's listed lot / code information

a) REF DM405A, UDI/DI 00653160322217 (case), 10653160322214 (unit), Lot Numbers: 2022042580, 2022070580, 2022071180, 2022071880, 2022072580, 2022080180, 2023040380, 2023050180, 2023073180, 2023102380;    b) REF DM640, UDI/DI 00653160289602 (case), 10653160289609 (unit), Lot Numbers:  2022041390;   c) REF DM600, UDI/DI 00653160352610 (case), 10653160352617 (unit), Lot Numbers:  2022041880, 2023081480;   d) REF DM870A, UDI/DI 00653160348217 (case), 10653160348214 (unit), Lot Numbers: 2022020780;    e) REF DM870A, UDI/DI 00653160352382 (case), 10653160352389 (unit), Lot Numbers:   2022041880;   f) REF DT21465B, UDI/DI 00653160350005 (case), 10653160350002 (unit), Lot Numbers: 2022012550, 2022032880, 2022032980, 2022082280;    g) REF DT18905, UDI/DI 00653160275063 (case), 10653160275060 (unit), Lot Numbers:  2022040590, 2022041390, 2022081990, 2023011290, 2023012490, 2023051190, 2023061290, 2023081590, 2023101790;   h) REF DM610, UDI/DI 00653160294002 (case), 10653160294009 (unit), Lot Numbers:  2022050980, 2022072580, 2022072680, 2022080180, 2022080880, 2022081580, 2023050880, 2023061280, 2023072480, 2023081480, 2023082880;   i) REF DT18210, UDI/DI 00653160352658 (case), 10653160352655 (unit), Lot Numbers: 2022042290;    j) REF DT18695A, UDI/DI 00653160315127 (case), 10653160315124 (unit), Lot Numbers: 2022042790, 2022103190, 2023012790, 2023032490, 2023032890, 2023052690, 2023072890, 2023092190;   k) REF DM630, UDI/DI 00653160288568 (case), 10653160288565 (unit), Lot Numbers:  2022033190;   l) REF DM630, UDI/DI 00653160352450 (case), 10653160352457 (unit), Lot Numbers:  2022050590, 2022111790, 2023011990, 2023031590, 2023042490, 2023062690, 2023081490;   m) REF DT19005A, UDI/DI 00653160349801 (case), 10653160349808 (unit), Lot Numbers:   2022050980;     n) REF DM1060, UDI/DI 00653160352443 (case), 10653160352440 (unit), Lot Numbers:  2022050280, 2023070380, 2023082180, 2023082880, 2023101680;   o) REF DM525A, UDI/DI 00653160352511 (case), 10653160352518 (unit), Lot Numbers:  2022042580, 2022080180, 2022112880, 2022112980;   p) REF DM850, UDI/DI 00653160307047 (case), 10653160307044 (unit), Lot Numbers: 2022040490;    q) REF DT17355, UDI/DI 00653160265170 (case), 10653160265177 (unit), Lot Numbers:  2022082290, 2022090190, 2022112990, 2023012490, 2023042090, 2023070690, 2023073190, 2023081190;   r) REF DT19835B, UDI/DI 00653160350128 (case), 10653160350125 (unit), Lot Numbers:  2022021150, 2022022250;   s) REF DT22575A, UDI/DI 00653160349825 (case), 10653160349822 (unit), Lot Numbers: 2022011350, 2022052380, 2022052480, 2022052580;    t) REF DT20845B, UDI/DI 00653160348842 (case), 10653160348849 (unit), Lot Numbers: 2022010750, 2022031450;    u) REF DT20885B, UDI/DI 00653160348422 (case), 10653160348429 (unit), Lot Numbers:  2022052380;   v) REF DT21585B, UDI/DI 00653160351439 (case), 10653160351436 (unit), Lot Numbers:   2022042050, 2022051680;   w) REF DYNDC2815A, UDI/DI 00653160348316 (case), 10653160348313 (unit), Lot  Numbers:  2022031450, 2022041180, 2022041280, 2022041380, 2022062080;   x) REF DT22270A, UDI/DI 00653160348255 (case), 10653160348252 (unit), Lot Numbers: 2022011350, 2022022880;    y) REF DM330A, UDI/DI 00653160324051 (case), 10653160324058 (unit), Lot Numbers:  2023081090, 2022042580, 2022103180, 2023020680, 2023042480;   z) REF DM330A, UDI/DI 00653160366655 (case), 10653160366652 (unit), Lot Numbers:  2023101190;   aa) REF DM875, UDI/DI 00653160309614 (case), 10653160309611 (unit), Lot Numbers:  2022040490;   bb) REF DM875, UDI/DI 00653160352504 (case), 10653160352501 (unit), Lot Numbers:  2022041290, 2022042590, 2022051990, 2022081990, 2022120990, 2023042790, 2023053090, 2023071490, 2023101290;   cc) REF DM1105, UDI/DI 00653160343519 (case), 10653160343516 (unit), Lot Numbers:  2022032490

Recall status

Ongoing — the recall is still being carried out.

Where it was distributed

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

Recall record

Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product type: Devices
Recall number: Z-1136-2024
Voluntary / mandated: Voluntary: Firm initiated
Initial notification: Letter
Origin: Northfield, IL
Recall initiated: 2023-11-15

What to do

Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.

Also available: structured data (JSON-LD) · recall record (JSON)

What this is — and is not

A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.

To report a problem you experienced, use FDA MedWatch. Verify this record at FDA recalls · Recall Z-1136-2024 · Source: openFDA enforcement.