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) ASC GENERAL MINOR CDS, REF CDS983673G; b) ASC GENERAL MINOR CDS, REF CDS983673I; c) C NURSE BAG KIT, REF DYKM1425; d) DAILY DRIVELINE MGMT KIT w/PER, REF DT18700; e) GASTRIC CULTURE PACK, REF DYNJ53966A; f) GASTRIC CULTURE PACK, REF DYNJ53966AH; g) HERNIA, REF CDS982034R; h) HERNIA, REF CDS982034S; i) HERNIA PACK, REF DYNJ39331B; j) LAP APPY PACK, REF DYNJ37709J; k) LAP CHOLE CDS, REF CDS983912V; l) LAP CHOLE CDS, REF CDS983912W; m) LAP CHOLE CDS, REF CDS983912X; n) LAP CHOLE CDS, REF CDS983912Y; o) LAPAROSCOPY PACK, REF DYNJ41417J; p) LAPAROTOMY CDS-LF, REF CDS860091A; q) LOWER EXTREMITY, REF DYNJ46222M; r) MAJOR PACK, REF DYNJ80578A; s) MINOR PACK, REF DYNJ67217D; t) N L MINOR CDS, REF CDS982518O; u) N L MINOR CDS, REF CDS982518P; v) NON STERILE I&D KIT, REF DYKM1438; w) PACK,GU MINOR, REF DYNJ906885B; x) PLASTICS SUTURE TRAY, REF SUT13535; y) RESPIRATORY KIT, REF DYKM1404; z) TRACH CARE TRAY, REF DYNDJ1057A;
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 CDS983673G, UDI/DI 40193489951746 (case), 10193489951745 (unit), Lot Numbers: 22EDA378, 22EDB208; b) REF CDS983673I, UDI/DI 40195327147335 (case), 10195327147334 (unit), Lot Numbers: 22GBJ096, 22GBJ097, 22HBR769, 22KBN934, 23ABH521, 23ABM586, 23BBR709, 23DBL344; c) REF DYKM1425, UDI/DI 40889942511236 (case), 10889942511235 (unit), Lot Numbers: 22DLA695, 22FLA284, 22GLA016, 22ILA012, 22ILA463, 22KLA336, 23ALA341, 23BLA132, 23DLB048, 23ELA454, 23FLA774, 23HLA165, 23ILB030, 23JLA435; d) REF DT18700, UDI/DI 653160275087 (case), 10653160275084 (unit), Lot Numbers: 23EBC489; e) REF DYNJ53966A, UDI/DI 40889942964681 (case), 10889942964680 (unit), Lot Numbers: 23CMB869, 23DMG880, 23EMG449, 23FMC889, 23HMA233, 23IMD181; f) REF DYNJ53966AH, UDI/DI 40889942964681 (case), 10889942964680 (unit), Lot Numbers: 23CMB869, 23DMG880, 23EMG449, 23FMC889, 23HMA233, 23IMD181, g) REF CDS982034R, UDI/DI 40195327003740 (case), 10195327003739 (unit), Lot Numbers: 21LBB488, 21LBC635, 22HBW422; h) REF CDS982034S, UDI/DI 40195327295364 (case), 10195327295363(unit), Lot Numbers: 23ABB710, 23BBA114, 23EBB482; i) REF DYNJ39331B, UDI/DI 40889942731580 (case), 10889942731589 (unit), Lot Numbers: 22HBH194, 22JBE708, 22LBL321, 23GBV891, 23IBA384; j) REF DYNJ37709J, UDI/DI 40193489376075 (case), 10193489376074 (unit), Lot Numbers: 22FMG179; k) REF CDS983912V, UDI/DI 40195327057146 (case), 10195327057145 (unit), Lot Numbers: 22BBX974, 22DBG451, 22DBO438, 22FBM809; l) REF CDS983912W, UDI/DI 40195327238408 (case), 10195327238407 (unit), Lot Numbers: 22KBI248, 23CBC518, 23DBM244; m) REF CDS983912X, UDI/DI 40195327403141 (case), 10195327403140 (unit), Lot Numbers: 23EBK644; n) REF CDS983912Y, UDI/DI 40195327417827 (case), 10195327417826 (unit), Lot Numbers: 23FBS625, 23HBD741, 23HBO315, 23IBC397, 23IBM310; o) REF DYNJ41417J, UDI/DI 40195327220991 (case), 10195327220990 (unit), Lot Numbers: 23FBQ267; p) REF CDS860091A, UDI/DI 40884389018324 (case), 10884389018323 (unit), Lot Numbers: 22ABW443, 22CBU907, 22FMA320, 22GMH940, 22IMI179, 22KMA029, 23AMJ550, 23CMF095, 23FMI870, 23GMF353; q) REF DYNJ46222M, UDI/DI 40195327437566 (case), 10195327437565 (unit), Lot Numbers: 23GBP791; r) REF DYNJ80578A, UDI/DI 40195327063819 (case), 10195327063818 (unit), Lot Numbers: 22FBO880; s) REF DYNJ67217D, UDI/DI 40195327278022 (case), 10195327278021 (unit), Lot Numbers: 23DBC699, 23EBB789, 23GBC854, 23GBP633; t) REF CDS982518O, UDI/DI 40195327247387 (case), 10195327247386 (unit), Lot Numbers: 23ABD137; u) REF CDS982518P, UDI/DI 40195327318858 (case), 10195327318857 (unit), Lot Numbers: 23BBM210; v) REF DYKM1438, UDI/DI 40889942529965 (case), 10889942529964 (unit), Lot Numbers: 22DDB583, 22FDA732, 22HDA409, 22JDA278, 22LDA778, 23BDB559, 23FDC186, 23IDA954; w) REF DYNJ906885B, UDI/DI 40193489972543 (case), 10193489972542 (unit), Lot Numbers: 22GBF087; x) REF SUT13535, UDI/DI 40193489440271 (case), 10193489440270 (case), Lot Numbers: 23GBD750; y) REF DYKM1404, UDI/DI 40889942473831 (case), 10889942473830 (unit), Lot Numbers: 22JBQ565, 23CBG138, 23EBO035, 23EBW986, 23GBP589; z) REF DYNDJ1057A, UDI/DI 40888277204790 (case), 10888277204799 (unit), Lot Numbers: 23DBC974
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-1102-2024
- 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-1102-2024 · Source: openFDA enforcement.