Centurion Kits, trays, and packs labeled as follows: a) A C DAILY WET KIT, REF DM405A; b) BW...
FDA Device Recall #Z-1136-2024 — Class I — November 15, 2023
Recall Summary
| Recall Number | Z-1136-2024 |
| Classification | Class I — Serious risk |
| Date Initiated | November 15, 2023 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | MEDLINE INDUSTRIES, LP - Northfield |
| Location | Northfield, IL |
| Product Type | Devices |
| Quantity | 113249 units |
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.
Distribution Pattern
Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama
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
Other Recalls from MEDLINE INDUSTRIES, LP - Northfield
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2567-2025 | Class I | Medline medical convenience kits labeled as: ... | Jul 25, 2025 |
| Z-2566-2025 | Class I | Medline medical convenience kits labeled as: ... | Jul 25, 2025 |
| Z-2479-2025 | Class II | Medline Kits containing BD SureStep Foley Tray ... | Jul 23, 2025 |
| Z-2460-2025 | Class I | Medline ReNewal Reprocessed St. Jude Medical Re... | Jul 14, 2025 |
| Z-2452-2025 | Class II | The Medline General Surgery Tray is customized ... | Jul 8, 2025 |
Frequently Asked Questions
Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.