FDA Device recall Z-2230-2024
Non-sterile convenience kits: a. Medline Difficult Airway Tray W/O Cook, Pack #ACC010578, containing a Pure Pouch with component Reorder #D…
- FDA Device
- Class II
- ongoing
- Published 2024-07-10
On 2024-07-10 the FDA classified a Class II recall of Non-sterile convenience kits: a. Medline Difficult Airway Tray W/O Cook, Pack #ACC010578, containing a Pure Pouch with component Reorder #D… by Medline Industries Northfield, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2230-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-03-14 |
| Published | 2024-07-10 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medline Industries Northfield |
| Distribution | US |
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.
Identifiers
| code_info | a. Pack #ACC010578 - Lot number 24ADA089, exp. 12/31/2024, UDI-DI each-10195327085605 and UDI-DI case 40195327085606.…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2230-2024%22
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