FDAFDA · Food and drugs·Recall number Z-2230-2024
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.
Published July 10, 2024 · Recall initiated: March 14, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Distributor
- 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.
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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