Recall archive / FDA device enforcement
Centurion Kits, trays, and packs labeled as follows: a) A C DAILY WET KIT, REF DM405A; b) BWH DAILY DRIVELINE MGMT KI... — FDA record Z-1136-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Nov 15, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 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
- 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.
- Classification
- Class I
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 113249 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1136-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Mar 6, 2024
- Recall initiation date
- Nov 15, 2023
- Center classification date
- Feb 24, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.