Reported Mar 6, 2024 · Ongoing
Medline Kits, trays, and packs labeled as follows
MEDLINE INDUSTRIES, LP - Northfield
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: MEDLINE INDUSTRIES, LP - Northfield · 3 Lakes Dr · Northfield, IL · 60093-2753
Is this the product you have?
Medline Kits, trays, and packs labeled as follows
26 of 26 products
| Model / number | Product as published |
|---|---|
CVI4705 | CENTRAL LINE TRAY |
DT18700 | DAILY DRIVELINE MGMT KIT w/PER |
DYNDC3131A | DRESSING CHANGE TRAY |
DT17405A | DRIVELINE MAINTENANCE PACKAGE |
DT21460B | DRSG CHANGE TRAY W/ CHG |
DT21460BH | DRSG CHANGE TRAY W/ CHG |
DM580 | LVAD MANAGEMENT SYSTEM - ACUTE |
DM580H | LVAD MANAGEMENT SYSTEM - ACUTE |
DYNDC3120A | PEDIATRIC PORT KIT W/ DRESSING |
DYNDC3081 | PORT ACCESS DRSG KIT W OUT CHG |
DYNDC3080 | PORT ACCESS DRSG KIT WITH CHG |
DYNJ0352159D | PORT ACCESS PACK-LF |
DT22810 | PORT DRESSING CHANGE KIT |
DT20640B | PORT DRESSING CHANGE TRAY |
DYNDC3052A | PORT DRESSING CHANGE TRAY |
DYNDC3052AH | PORT DRESSING CHANGE TRAY |
DYKM1528 | POST OP,20-DAY SUPPLY 40/CS |
DYKM1528H | POST OP,20-DAY SUPPLY 40/CS |
DYNDA2937 | SALINE GAUZE DRESSING TRAY |
DYNDA2937A | SALINE GAUZE DRESSING TRAY |
- Lot codes and dates
26 of 26 products
Products covered by this recall Model / number Barcodes Product as published CVI47054019532705612510195327056124UDI/DI 40195327056125 (case), 10195327056124 (unit), Lot Numbers: 23FMD562 DT1870065316027508710653160275084UDI/DI 653160275087 (case), 10653160275084 (unit), Lot Numbers; 23BBJ923, 23CBB549, 23FBM548, 23GBF094, 23GBR827, 23HBM237 DYNDC3131A4019532710569410195327105693UDI/DI 40195327105694 (case), 10195327105693 (unit), Lot Numbers: 22CBJ619, 22DBD254, 22IBG214 — 4065316099161910653160991618DT17405A, UDI/DI 40653160991619 (case), 10653160991618 (unit), Lot Numbers: 22CBY954, 22DBB495, 22DBH244, 22HBT273 — 4065316099157210653160991571DT21460B, UDI/DI 40653160991572 (case), 10653160991571 (unit), Lot Numbers: 22ABZ051, 22OBC041 — 4065316099157210653160991571DT21460BH, UDI/DI 40653160991572 (case), 10653160991571 (unit), Lot Numbers: 22ABZ051, 22OBC041 — 65316028698410653160286981DM580, UDI/DI 653160286984 (case), 10653160286981 (unit), Lot Numbers: 22EBB241, 22FBE733, 22JBR597, 23ABL651, 23BBB038, 23CBU481, 23FBD719, 23GBN340, 23IBE764, 23IBT300 — 65316028698410653160286981DM580H, UDI/DI 653160286984 (case), 10653160286981 (unit), Lot Numbers: 22EBB241, 22FBE733, 22JBR597, 23ABL651, 23BBB038, 23CBU481, 23FBD719, 23GBN340, 23IBE764, 23IBT300 — 4019532705612510195327056124DYNDC3120A, UDI/DI 40195327056125 (case), 10195327056124 (unit), Lot Numbers: 23AME583, 23FMC905 — 4019348984974610193489849745DYNDC3081, UDI/DI 40193489849746 (case), 10193489849745 (unit), Lot Numbers: 22CBG508 — 4019348984973910193489849738DYNDC3080, UDI/DI 40193489849739 (case), 10193489849738 (unit), Lot Numbers: 22BBR416, 2EBD704 — 4019532705612510195327056124DYNJ0352159D, UDI/DI 40195327056125 (case), 10195327056124 (unit), Lot Numbers: 23AME774 — 4065316099336110653160993360DT22810, UDI/DI 40653160993361 (case), 10653160993360 (unit), Lot Numbers: 22IBI823 — 4065316099167110653160991670DT20640B, UDI/DI 40653160991671 (case), 10653160991670 (unit), Lot Numbers: 22ABT093, 22JBB214 — 4019532716012910195327160128DYNDC3052A, UDI/DI 40195327160129 (case), 10195327160128 (unit), Lot Numbers: 22LMI145 — 4019532716012910195327160128DYNDC3052AH, UDI/DI 40195327160129 (case), 10195327160128 (unit), Lot Numbers:22LMI145 — 4088994268992810889942689927DYKM1528, UDI/DI 40889942689928 (case), 10889942689927 (unit), Lot Numbers: 22HBZ240, 22KBR167 — 4088994268992810889942689927DYKM1528H, UDI/DI 40889942689928 (case), 10889942689927 (unit), Lot Numbers: 22HBZ240, 22KBR167 — 4019532713237910195327132378DYNDA2937, UDI/DI 40195327132379 (case), 10195327132378 (unit), Lot Numbers: 22JBK727, 22JBT535, 23CBX574 — 4019532713237910195327132378DYNDA2937A, UDI/DI 40195327132379 (case), 10195327132378 (unit), Lot Numbers:23DBF619, 23EBK506, 23FBF438, 23HBN471, 23IBN607 - Amount recalled
- 86699 units
This recall covers 49 products
The agency filed one notice per product. You are reading one of them; the other 48 are below.
36 more are in the archive.
Where it was sold
- Nationwide
- PR
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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