Recall archive / FDA device enforcement
Non-sterile convenience kits: a. Medline Difficult Airway Tray W/O Cook, Pack #ACC010578, containing a Pure Pouch wit... — FDA record Z-2230-2024
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 Mar 14, 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
- Non-sterile convenience kits: a. Medline Difficult Airway Tray W/O Cook, Pack #ACC010578, containing a Pure Pouch with component Reorder #DYNJ040408, Kelly Forceps/STD STR Sterile. b. Medline Adult/Child Intubation Kit, Pack #ACC010616 and Pack #ACC010616H, containing a Pure Pouch with component Reorder #66790, Sterile Magill Forceps. c. Medline Intubation Tray (Adult), Pack #DYNJAA245A, containing a Pure Pouch with component Reorder #66790, Sterile Magill Forceps. d. Medline Adult Main Disp. Intub Part A, Pack #DYNJAA262A, containing a Pure Pouch with component Reorder #66790, Sterile Magill Forceps. e. Medline Adult Anesthesia Tray, Pack #DYNJAA276, containing a Pure Pouch with component Reorder #66790, Sterile Magill Forceps. f. Medline Baby Care Kit, Pack #DYKL1025 and Pack #DYKL1025H, containing a Pure Pouch with component Reorder #DYND04000, O.R. Scissors, S/B, 5.5 Sterile.
- Reason
- Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails.
- Classification
- Class II
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 7,673 total non-sterile kits
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2230-2024
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. Pack #ACC010578 - Lot number 24ADA089, exp. 12/31/2024, UDI-DI each-10195327085605 and UDI-DI case 40195327085606. b. Pack #ACC010616 and Pack #ACC010616H - Lot numbers 23IDA976, exp. 10/31/2024; 23IDA980, exp. 11/30/2024; 23HDA517, exp. 9/30/2024; and 23DDB062, exp. 4/30/2024. c. Pack #DYNJASA245A - Lot number 23JBT059, exp. 4/30/2025, UDI-DI each-10193489804584 and UDI-DI case-40193489804585. d. Pack #DYNJAA262A - Lot number 23GBJ039, exp. 9/30/2024, UDI-DI each-10195327208172 and UDI-DI case-40195327208173. e. Pack #DYNJAA276 - Lot number 23GBG661, exp. 8/31/2024, UDI-DI each-10195327338534 and UDI-DI case-40195327338535. f. Pack #DYKL1025 and Pack #DYKL1025H - Lot numbers 24ABY293, exp. 3/31/2026; 23LBD262, exp. 9/30/2024; 23IBN598, exp. 7/31/2024; 23GBF800, 8/31/2025; 23FBI255, exp. 2/28/2025, and 23CBT397, exp. 11/30/2024. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Nationwide distribution in the states of AL, CA, CO, CT, FL, IL, IN, MD, MN, MT, NC, NJ, NV, NY, OH, PA, SC, TN, TX, VA, WA, WI, and WY.
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
- Jul 10, 2024
- Recall initiation date
- Mar 14, 2024
- Center classification date
- Jun 28, 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.