—#205722

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

FDA product code: OXQ — Dressing Change Tray
Device class: Class 1
Medical specialty: General Hospital
Affected lot / code info: 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

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.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

MEDLINE issued an IMMEDIATE ACTION REQUIRED NURSE ASSIST PRODUCT RECALL notice to its consignees on 11/16/2023 via USPS first class mail and email. The notice explained the problem, requested log on to their portal to identify the products and check their inventory so the product could be quarantined. Once Medline receives the completed response form, over-labels will be shipped to the consignee. Medline Industries, LP instructed customers to over-label the convenience kits with a warning label indicating to remove the sodium chloride irrigation or Sterile water and replace from a different sterile supply. Distributors or consignees who further distributed the affected products were directed to notify their customers. For questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.

Recalling firm

Firm: MEDLINE INDUSTRIES, LP Northfield
Address: 3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

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

Timeline

Recall initiated: 2023-11-15
Posted by FDA: 2024-02-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #205722. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.