Recall Register

Device recall: MEDLINE TRAY TRACH BASIC SOLUTION, REF DYND40511

Class I FDA enforcement event 93800. Recall start date: . Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

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.

Class I, in the words of FDA

a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death

MEDLINE INDUSTRIES, LP - Northfield started this device recall on 15 Nov 2023. The firm address in the FDA record is in Northfield, IL. FDA put the recall in Class I. FDA event 93800 has 49 product records. The first FDA enforcement report date is 6 Mar 2024. The record gives the status Ongoing.

FDA enforcement reportThe 49 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Distribution

In the words of FDA.

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

Recalling firm

MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

49 product records in the event.

FDA event 93800: product records
Recall numberProductQuantityClassStatusReport date
Z-1090-2024MEDLINE TRAY TRACH BASIC SOLUTION, REF DYND40511385028 traysClass IOngoing6 Mar 2024
Z-1091-2024MEDLINE TRAY care and cleaning kits and trays for Tracheostomy and Stomas, labeled as: a) STOMA & TRACH CLEANING KIT, REF DYNDJ1129; b) TRACH CARE TRAY, REF DYNDJ1057A; c) TRACHEOSTOMY CARE KIT, REF DYNDA1893A; d) TRACH CARE TRAY, REF DYNDA14822683387 unitsClass IOngoing6 Mar 2024
Z-1092-2024MEDLINE kits and trays, labeled as: a) SUCTION CATH 10FR KIT W/SALINE, REF DYND41470SA, DYND41470SAH; b) TRACH CARE TRAY, REF DYNDA1931B, DYNDA1931BH385028 unitsClass IOngoing6 Mar 2024
Z-1093-2024MEDLINE BRONCHOSCOPY TRAY, REF DYNDL1350AClass IOngoing6 Mar 2024
Z-1094-2024MEDLINE ARTERIAL BUNDLE NO CATHETER, REF ART995Class IOngoing6 Mar 2024
Z-1095-2024MEDLINE Kits, trays, and packs labeled as follows: a) CATH LAB CDS, REF CDS840228F; b) PEDIATRIC PORT A CATH TRAY, REF DYNDC2128B; c) PK, RADIOLOGY, REF DYNJ44087A; d) PORT ACCESS PACK-LF, REF DYNJ0352159C; DYNJ0352159D385028 unitsClass IOngoing6 Mar 2024
Z-1096-2024MEDLINE 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…Class IOngoing6 Mar 2024
Z-1097-2024MEDLINE Kits, trays, and packs labeled as follows: a) ARTERIAL LINE PACK, REF DYNJ65208A; b) CANCER SERVICE PORT KIT, REF DT22710; c) CAP CHANGE KIT, REF DYNDC2002A; d) CAP CHANGE KIT, REF DYNDC2723A; e) CAP CHANGE KIT, REF DYNDC2723B; f) CENTRAL LINE INSERTION PACK, REF CVI4805; g) CENTRAL LINE TRAY, REF CVI4705; h)…Class IOngoing6 Mar 2024
Z-1098-2024MEDLINE Kits, trays, and packs labeled as follows: a) Description, REF DYNDH1679; b) BREAST BIOPSY TRAY, REF DYNDH1664; c) BREAST BIOPSY TRAY, REF DYNDH1431A; d) BREAST BIOPSY TRAY, REF DYNJ46448; e) BREAST BIOPSY TRAY, REF DYKE1520B; f) COLON KIT- BERLIN, REF DYNDH1808;Class IOngoing6 Mar 2024
Z-1099-2024Centurion Kits, trays, and packs labeled as follows: MAINTENANCE FLUSH KIT/BLOOD DRAW, REF DT19335AClass IOngoing6 Mar 2024
Z-1100-2024MEDLINE Kits, trays, and packs labeled as follows: SERUM TEAR KIT, REF DYNDA1545Class IOngoing6 Mar 2024
Z-1101-2024MEDLINE Kits, trays, and packs labeled as follows: a) ASC MINOR THYROID CDS, REF CDS983682F; b) BRONCHOSCOPY KIT, REF DYKE1718A; c) BRONCHOSCOPY KIT, REF DYKE1718B; d) DOUBLE CENTRAL LINE CAP CHANGE, REF DYNDC2214G; e) ENT PACK, REF DYNJ55334C; f) ENT PACK, REF DYNJ45175B; g) ENT PACK, REF DYNJ59030A; h) ENT PACK,…Class IOngoing6 Mar 2024
Z-1102-2024MEDLINE 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…3297 unitsClass IOngoing6 Mar 2024
Z-1103-2024MEDLINE Kits, trays, and packs labeled as follows: a) C-SECTION, REF DYNJ904653G; b) DRESSING TRAY, REF M101426; c) ENDO KIT, REF DYKE1387; d) ENDO KIT, REF DYKE1364B; e) ENDO KIT, REF DYKE1892; f) ENDO KIT W/ BLUE TOTE BAG, REF DYKE1648I; g) EYE KIT, REF DYKM2222; h) LAP CHOLE CDS, REF CDS983912Y; i) PLASTICS SUTURE…5969 unitsClass IOngoing6 Mar 2024
Z-1104-2024MEDLINE Kits, trays, and packs labeled as follows: CATHETERIZATION KIT, REF DYNDA293918 unitsClass IOngoing6 Mar 2024
Z-1105-2024MEDLINE Kits, trays, and packs labeled as follows: DIALYSIS ON/OFF BNDLE -NO DRSG, REF DYNDC308835 unitsClass IOngoing6 Mar 2024
Z-1106-2024MEDLINE Kits, trays, and packs labeled as follows: a) ENDO KIT, REF DYKE1350D; b) PANENDOSCOPY-LF, REF DYNJ36728C; c) UMBILICAL VESSEL INSERTION, REF UVT1170; d) UMBILICAL VESSEL INSERTION, REF UVT1170H1184 unitsClass IOngoing6 Mar 2024
Z-1107-2024Centurion Kits, trays, and packs labeled as follows: a) DIALYSIS ACCESSORY PACK W/O CATHETER, REF MNS10750A; b) DIALYSIS ON KIT, REF DT21235A; c) INFUSA PORT KIT, REF DYNDC3166A10391 unitsClass IOngoing6 Mar 2024
Z-1108-2024Medline Kits, trays, and packs labeled as follows: TRAY,L&D INSTRUMENT, REF DYNDL1550228 unitsClass IOngoing6 Mar 2024
Z-1109-2024Medline Kits, trays, and packs labeled as follows: a) BREAST PACK, REF DYNJ56344B; b) SEPTOPLASTY PACK WRO-LF, REF DYNJ62803139 unitsClass IOngoing6 Mar 2024
Z-1110-2024Medline Kits, trays, and packs labeled as follows: CHP WOUND IRRIGATION KIT, REF DYK1017614W2205 unitsClass IOngoing6 Mar 2024
Z-1111-2024Medline Kits, trays, and packs labeled as follows: a) 709E RECOVERY PACK A,B,C II SS, REF DYNJ55960G; b) ABDOMEN PACK, REF DYNJ53643C; c) BAG TRUNK STOCK KIT, REF DYKM1880; d) BEDSIDE BRONCH PACK, REF DYKE1601; e) BIOPSY TRAY, REF DYNDH1242; f) BRONCH KIT, REF DYKE1840; g) BRONCHOSCOPY PACK, REF DYNJ37775F; h)…26171 unitsClass IOngoing6 Mar 2024
Z-1112-2024Medline Kits, trays, and packs labeled as follows: a) LACERATION KIT, REF SUT13935; b) LACERATION TRAY, REF SUT21215; c) LACERATION TRAY, REF SUT15380; d) LACERATION TRAY W/SNAGFREE NEE, REF SUT19005; e) PLASTICS SUTURE TRAY, REF SUT13535; f) UVC INSERTION TRAY, REF UVT840A g) BRONCHOALVEOLAR LAVAGE PACK, REF…21154 unitsClass IOngoing6 Mar 2024
Z-1113-2024Medline Kits, trays, and packs labeled as follows: a) PORT ACCESS TRAY, REF DYNDA2863; b) PORT ACCESS TRAY, REF DYNDA2863H; c) ULTRASOUND GUIDED IV START KIT, REF DYNDV2518; d) ULTRASOUND GUIDED IV START KIT, REF DYNDV2518H; e) KIT ULTRASOUND PIV START, REF DYNDV2445; f) NICU INSERTION & DRSG CHG TRAY, REF EBSI1306A;…3900 unitsClass IOngoing6 Mar 2024
Z-1114-2024Medline Kits, trays, and packs labeled as follows: a) PORT REMOVAL PACK, REF DYNDA2936; b) PORT REMOVAL PACK, REF DYNDA2936H16 unitsClass IOngoing6 Mar 2024
Z-1115-2024Medline Kits, trays, and packs labeled as follows: a) BLOOD DRAW KIT, REF DYNDV2183A; b) LCPH LAB DRAW KIT, REF DYNDH1641A; c) LCPH LAB DRAW KIT, REF DYNDH1641AH; d) OB LAB COLLECTION KIT, REF DYNDH1719A;Class IOngoing6 Mar 2024
Z-1116-2024Medline Kits, trays, and packs labeled as follows: a) C L PREP, REF DYNJ69664; b) DMEK PREP PACK, REF DYNJ81659A; c) PRE OP KIT 1, REF DYKS1377; d) PRE OP KIT 1, REF DYKS1377A1270 unitsClass IOngoing6 Mar 2024
Z-1117-2024Medline Kits, trays, and packs labeled as follows: a) CENTRAL LINE TRAY, REF CVI4705; b) DAILY DRIVELINE MGMT KIT w/PER, REF DT18700; c) DRESSING CHANGE TRAY, REF DYNDC3131A; d) DRIVELINE MAINTENANCE PACKAGE, REF DT17405A; e) DRSG CHANGE TRAY W/ CHG, REF DT21460B; f) DRSG CHANGE TRAY W/ CHG, REF DT21460BH; g) LVAD…86699 unitsClass IOngoing6 Mar 2024
Z-1118-2024Medline Kits, trays, and packs labeled as follows: a) ER LACERATION TRAY - SNAG FREE, REF SUT12825; b) LACERATION TRAY, REF SUT21580; c) LACERATION TRAY, REF DYNDL1484B;12000 unitsClass IOngoing6 Mar 2024
Z-1119-2024Medline Kits, trays, and packs labeled as follows: a) TRACH CARE KIT, REF DYND40589; b) TRACH CARE KIT, REF DYNDA3004; c) TRACHEOSTOMY CARE TRAY, REF DYND40650; d) TRAY,TRACH,W/PCLNR,14FR CATH N, REF DYND40594991,744 unitsClass IOngoing6 Mar 2024
Z-1120-2024Medline Kits, trays, and packs labeled as follows: WOUND CARE TRAY - LATEX-FREE, REF DYND0600272,624 unitsClass IOngoing6 Mar 2024
Z-1121-2024Medline Kits, trays, and packs labeled as follows: a) NUR 105, REF EDUC05053B; b) NUR 213, REF EDUC05054B; c) NURSING SKILLS, REF EDUC05050B; d) NURSING SUPPLY BAG, REF EDUC1024844 unitsClass IOngoing6 Mar 2024
Z-1122-2024Medline Kits, trays, and packs labeled as follows: a) L&B CDS-LF, REF CDS980273D; b) LABOR AND DELIVERY, REF DYNJ907794; c) LACERATION TRAY, REF DYNDL1864A; d) OBSTETRICAL, REF DYNJ908877; e) UMC EP VAGINAL DELIVERY, REF DYNJ83093;2903 unitsClass IOngoing6 Mar 2024
Z-1123-2024Medline Kits, trays, and packs labeled as follows: a) GYN LAPAROSCOPY, REF CDS984900M; b) GYN LAPAROSCOPY CDS, REF CDS983913S; c) GYN LAPAROSCOPY CDS, REF CDS983913T; d) GYN LAPAROSCOPY CDS, REF CDS983913U; e) GYN LAPAROSCOPY CDS, REF CDS983913V533 unitsClass IOngoing6 Mar 2024
Z-1124-2024Medline Kits, trays, and packs labeled as follows: C-SECTION, REF DYNJ904653G483 unitsClass IOngoing6 Mar 2024
Z-1125-2024Medline Kits, trays, and packs labeled as follows: a) D&C CDS, REF CDS983911J; b) D&C PACK, REF DYNJ67214F; c) D&C PACK, REF DYNJ67214G279 unitsClass IOngoing6 Mar 2024
Z-1126-2024Medline Kits, trays, and packs labeled as follows: a) CATARACT PACK, REF VAL011CTASD; b) CATARACT PACK, REF DYNJ68875F; c) CATARACT PACK, REF DYNJ54869F; d) CATARACT PREP PACK, REF DYNJ44917L; e) E-BLEPH CDS, REF CDS983585G; f) EYE CDS, REF CDS983916G; g) EYE KIT, REF DYKM2222; h) EYE PLASTIC PACK, REF DYNJ47859C; i)…5724 unitsClass IOngoing6 Mar 2024
Z-1127-2024Medline Kits, trays, and packs labeled as follows: a) ANTERIOR PACK, REF DYNJ64814A; b) ARTHROGRAM TRAY, REF DYNDH1629; c) CVL INSERTION KIT-LF, REF DYNJ48587A; d) EXTREMITY CDS, REF CDS983313I; e) EXTREMITY CDS, REF DYNJ902004D; f) EXTREMITY CDS, REF DYNJ902004F; g) EXTREMITY IV, REF CMPJ06040D; h) EXTREMITY IV, REF…14280 unitsClass IOngoing6 Mar 2024
Z-1128-2024Medline Kits, trays, and packs labeled as follows: a) KIT,SUCTION CATH,10FR W/WATER, REF DYND41470; b) KIT,SUCTION CATH,12FR W/H20 12, REF DYND41471; c) KIT,SUCTION CATH,14FR W/SALIN, REF DYND40442; d) KIT,SUCTION CATH,14FR W/WATER, REF DYND41472; e) KIT,SUCTION CATH,18FR W/H20, REF DYND41474; f) KIT,SUCTION…1,012,700 unitsClass IOngoing6 Mar 2024
Z-1129-2024Centurion Kits, trays, and packs labeled as follows: MAINTENANCE FLUSH KIT/BLOOD DRAW, REF DT19335A220 unitsClass IOngoing6 Mar 2024
Z-1130-2024Centurion Kits, trays, and packs labeled as follows: a) DIALYSIS ACCESSORY PACK W/O CATHETER, REF MNS10750A; b) DIALYSIS ON KIT, REF DT21235A; c) INFUSA PORT KIT, REF DYNDC3166A10391 unitsClass IOngoing6 Mar 2024
Z-1131-2024Centurion Kits, trays, and packs labeled as follows: EYE PREP KIT, REF ET101060 unitsClass IOngoing6 Mar 2024
Z-1132-2024Centurion Kits, trays, and packs labeled as follows: a) BASIC PROCEDURE TRAY, REF MNS13600; b) BWH DAILY DRIVELINE MGMT KIT, REF DM640A; c) CIRCUMCISION TRAY, REF CIT6180; d) INCISION & DRAINAGE TRAY, REF ID1690; e) LACERATION TRAY, REF SUT19510; f) LACERATION TRAY, REF SUT19510; g) LACERATION TRAY, REF SUT8565; h)…14234 unitsClass IOngoing6 Mar 2024
Z-1133-2024Centurion Kits, trays, and packs labeled as follows: LATEX FREE TRACHEOSTOMY CARE TRAY, REF TC7170528 unitsClass IOngoing6 Mar 2024
Z-1134-2024Centurion Kits, trays, and packs labeled as follows: a) IV SECUREMENT KIT, REF IVS1860B; b) NEONATAL PICC LINE INSERTION TRAY, REF CVI2025; c) NEONATAL PICC LINE INSERTION TRAY, REF CVI4570; d) SECONDARY IV START KIT, REF IV8695A11812 unitsClass IOngoing6 Mar 2024
Z-1135-2024Centurion Kits, trays, and packs labeled as follows: LACERATION TRAY, REF ST11670A576 unitsClass IOngoing6 Mar 2024
Z-1136-2024Centurion 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…113249 unitsClass IOngoing6 Mar 2024
Z-1137-2024Centurion Kits, trays, and packs labeled as follows: BREAST BIOPSY KIT, REF MNS4360120 unitsClass IOngoing6 Mar 2024
Z-1138-2024Centurion Kits, trays, and packs labeled as follows: CIRCUMCISION TRAY, REF DYNDA22711260 unitsClass IOngoing6 Mar 2024

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class I: The highest of the three FDA recall classes.

The event in context

Device events that started in 2023
917
Share of these events in Class I
10%
Product records in this event
49Median of the firm: 2
Events of the firm on the register
120

Other events of the firm

Other FDA enforcement events of MEDLINE INDUSTRIES, LP - Northfield
InitiatedProduct (first record)TypeClassRecords
25 Jul 2025Medline medical convenience kits labeled as: 1. ADULT INTUBATION TRAY, Kit Number ACC010369B; 2. ADULT ICU INTUBATION TRDeviceClass I2
23 Jul 2025Medline Kits containing BD SureStep Foley Tray Systems: SKU/Description: CDS984076J GYN ROBOTIC DYNJG001004A LAVH MINOR DeviceClass II1
14 Jul 2025Medline ReNewal Reprocessed St. Jude Medical Response and Supreme Diagnostic Electrophysiology Catheter Models 401150RH,DeviceClass I1
8 Jul 2025The Medline General Surgery Tray is customized to meet requirements of the hospitals and health care professionals utiliDeviceClass II1
7 Jul 2025Medline Alcohol Prep Pads, 70% Isopropyl Alcohol, 100 Sterile 2-Ply Pads, Single Use Only, Large, www.medline.com, ManufDrugClass II6
16 Jun 2025SwabFlush Prefilled Syringe with ICU Medical SwabCaps, 10mL Model no. EMZE010301DeviceClass II1
12 Jun 2025Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: LABOR TRIAGE KIT, REF DYKM1564DeviceClass II4
23 May 2025Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: 1) CC DRAWER DeviceClass II3
15 May 2025Medline UMBILICAL TRAY W/3.5&5FR CATH, REF UVT1250DeviceClass II1
22 Apr 2025Medline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI ADD A PACK, SKU DYNJ30926O 2. CRANIOTOMY, SKU CDS98DeviceClass I3

MEDLINE INDUSTRIES, LP - Northfield: all 120 events

Official channels

Cite this page

Recall Register. FDA enforcement event 93800. https://recallregister.com/fda/i/93800/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA device enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
Newest FDA report date on the register
23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?
The FDA record gives this distribution: Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama
What quantity of product is in FDA event 93800?
The event has 49 product records. The first record gives this quantity: 385028 trays
How did the recall start?
The FDA record says: Voluntary: Firm initiated
How many device recalls of 2023 have the same class?
10% of the 917 device events that started in 2023 are in Class I.