Recall archive / FDA device enforcement
Medline brand medical procedure convenience kits, labeled as: a) TRAY ADD A CATH FOL UM MF 10ML, REF DYND150200S; b) ... — FDA record Z-0164-2025
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 Sep 4, 2024. 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 brand medical procedure convenience kits, labeled as: a) TRAY ADD A CATH FOL UM MF 10ML, REF DYND150200S; b) TRAY FOL LATX UM COUD 16FR MF, REF DYND150216CS; c) TRAY FOLEY LTX 16FR 10ML UM MF, REF DYND150216S; d) TRAY FOLEY LTX 16FR 10ML UM MF, REF DYND150216S; e) TRAY FOL LATX UM COUD 18FR MF, REF DYND150218CS; f) TRAY FOLEY LTX 18FR 10ML UM MF, REF DYND150218S; g) TRAY FOLEY LTX 18FR 10ML UM MF, REF DYND150218S; h) TRAY FOLEY SIL 16FR 10ML W/UM, REF DYND150816; i) TRAY FOL SIL UM COUD 16FR MF, REF DYND150816CS; j) TRAY FOL SIL 16FR 10ML W/UM MF, REF DYND150816S; k) TRAY FOL SIL UM COUD 18FR MF, REF DYND150818CS; l) TRAY FOL SIL 18FR 10ML W/UM MF, REF DYND150818S
- Reason
- It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
- Classification
- Class II
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 8830 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0164-2025
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 DYND150200S, UDI/DI 40195327387885 (each), 10195327387884 (case), Lot Numbers: 23LBK182; b) REF DYND150216CS, UDI/DI 40195327388059 (each), 10195327388058 (case), Lot Numbers: 23LBK183; c) REF DYND150216S, UDI/DI 40195327387366 (each), 10195327387365 (case), Lot Numbers: 23LBO854; d) REF DYND150216S, UDI/DI 40195327387366 (each), 10195327387365 (case), Lot Numbers: 23LBL067; e) REF DYND150218CS, UDI/DI 40195327388066 (each), 10195327388065 (case), Lot Numbers: 23LBL068; f) REF DYND150218S, UDI/DI 40195327388004 (each), 10195327388003 (case), Lot Numbers: 23LBP852; g) REF DYND150218S, UDI/DI 40195327388004 (each), 10195327388003 (case), Lot Numbers: 23KBK538; h) REF DYND150816, UDI/DI 40195327043064 (each), 10195327043063 (case), Lot Numbers: 23KBE406; i) REF DYND150816CS, UDI/DI 40195327149919 (each), 10195327149918 (case), Lot Numbers: 23KBU812; j) REF DYND150816S, UDI/DI 40195327149711 (each), 10195327149710 (case), Lot Numbers: 24ABA832; k) REF DYND150818CS, UDI/DI 40195327149926 (each), 10195327149925 (case), Lot Numbers: 23LBH302; l) REF DYND150818S, UDI/DI 40195327149889 (each), 10195327149888 (case), Lot Numbers: 23KBF923 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, 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
- Oct 30, 2024
- Recall initiation date
- Sep 4, 2024
- Center classification date
- Oct 23, 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.