Recall archive / FDA device enforcement
MEDLINE TRAY care and cleaning kits and trays for Tracheostomy and Stomas, labeled as: a) STOMA & TRACH CLEANING KIT,... — FDA record Z-1091-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Nov 15, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- MEDLINE 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 DYNDA1482
- Reason
- 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.
- Classification
- Class I
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 2683387 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1091-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | a) REF DYNDJ1129, UDI/DI 40195327391400 (case), 10195327391409 (unit), Lot Numbers: 23EBD895, 23EBD896, 23EBD897, 23GBQ880; b) REF DYNDJ1057A, UDI/DI 40888277204790 (case), 10888277204799 (unit), Lot Numbers: 23ABA019, 23EBM580, 23HBU078; c) REF DYNDA1893A, UDI/DI 40193489866125 (case), 10193489866124 (unit), Lot Numbers: 23CBA077, 23CBI537, 23CBT627, 23DBF373, 23EBM582, 23HBV368, 23JBP946; d) REF DYNDA1482, UDI/DI 40889942131151 (case), 10889942131150 (unit), Lot Numbers: 2022040690, 2022052390, 2022102090, 2023011790 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Mar 6, 2024
- Recall initiation date
- Nov 15, 2023
- Center classification date
- Feb 24, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.