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.
MEDLINE Kits, trays, and packs labeled as follows: a) DIALYSIS FISTULA KIT, REF DYNDC3106, b) ENDO KIT, REF DYKE1346D, c) ENDO KIT, REF DYKE1892A, d) ENDO KIT W/ BLUE TOTE BAG, REF DYKE1648G, e) ENDO KIT W/ BLUE TOTE BAG, REF DYKE1648I, f) FREQUENT DAILY VAD, REF DYNDC3184, g) IMPLANTED VASCULAR ACCESS, REF DYNDC2842, h) INFANT COARTATION PACK, REF DYNJ54822D, i) INFANT OPEN HEART PUMP, REF DYNJ904068D, j) INFUSA PORT DRESSING KIT, REF DYNDC3192, k) LVAD DRIVELINE MANAGEMENT KIT, REF DM1165, l) LVAD DRIVELINE MANAGEMENT KIT, REF DM1165B, m) OPEN HEART ACCESSORY CDS, REF CDS984289K, n) PACEMAKER PK SHSC-LF, REF DYNJ46785C, o) PERICARDIAL KIT, REF DYNDA2212B, p) PK, RADIOLOGY-PORTSMOUTH, REF DYNJ44087B, q) PUH PERCUTANEOUS ECMO, REF DYNJ907554A, r) PUH PERCUTANEOUS ECMO, REF DYNJ907554C
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 DYNDC3106, UDI/DI 40193489913270 (case), 10193489913279 (unit), Lot Numbers: 21LBT706, 22CBE273; b) REF DYKE1346D, UDI/DI 40195327114085 (case), 10195327114084 (unit), Lot Numbers: 22GBO510, 23BBG861, 23CBM313, 23EBN617, 23FBU655, 23GBR877, 23IBH963; c) REF DYKE1892A, UDI/DI 40195327430963 (case), 10195327430962 (unit), Lot Numbers: 10195327430962; d) REF DYKE1648G, UDI/DI 40195327007127 (case), 10195327007126 (unit), Lot Numbers: 22BBY253, 22DBG793, 22EBM485, 22GBY046, 22JBQ585, 22LBJ398, 23CBG974; e) REF DYKE1648I, UDI/DI 40195327351541 (case), 10195327351540 (unit), Lot Numbers: DYKE1648I; f) REF DYNDC3184, UDI/DI 40195327034093 (case), 10195327034092 (unit), Lot Numbers: DYNDC3184; g) REF DYNDC2842, UDI/DI 40193489342568 (case), 10193489342567 (unit), Lot Numbers: DYNDC2842; h) REF DYNJ54822D, UDI/DI 40195327151813 (case), 10195327151812 (unit), Lot Numbers: i) REF DYNJ904068D, UDI/DI 22DMI181, 22GMH542, 23FMG372, 23GMC127; j) REF DYNDC3192, UDI/DI 40195327153251 (case), 10195327153250 (unit), Lot Numbers: 23BMF718, 23CME669, 23FMJ514, 23GMH712, 23IMA898; k) REF DM1165, UDI/DI 40653160994184 (case), 10653160994183 (unit), Lot Numbers: DYNDC3192; l) REF DM1165B, UDI/DI 40653160994184 (case), 10653160994183 (unit), Lot Numbers: 23BBA069, 23CBR900, 23DBR127, 23EBP048, 23GBF718, 23HBN448, 23JBB725, 23JBP425; m) REF CDS984289K, UDI/DI 40195327067244 (case), 10195327067243 (unit), Lot Numbers: 22FBX071, 22JBT625, 22LBQ630, 22OBI364, 23ABP719, 23CBI370, 23FBP065, 23FBV540; n) REF DYNJ46785C, UDI/DI 40888277789389 (case), 10888277789388 (unit), Lot Numbers: 22CBY383, 22HBI240, 22JBS870, 22LBR066, 23ABC131, 23BBJ268, 23BBK356, 23CBS913; o) REF DYNDA2212B, UDI/DI 20193489197386 (case), 10193489197389 (unit), Lot Numbers: 22ILA769, 22LLA799, 23BLB093, 23ELA493; p) REF DYNJ44087B, UDI/DI 40195327346585 (case), 10195327346584 (unit), Lot Numbers: 23BBR837, 23EBF536, 23FBL664, 23HBQ739, 23IBF826, 23JBR527, 23KBA577; q) REF DYNJ907554A, UDI/DI 40195327024636 (case), 10195327024635 (unit), Lot Numbers: DYNJ907554A; r) REF DYNJ907554C, UDI/DI 40195327183838 (case), 10195327183837 (unit), Lot Numbers: 22IBF009, 22IBF810, 23ABS408, 23DBE286
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-1096-2024
- 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-1096-2024 · Source: openFDA enforcement.