Class II — MEDLINE INDUSTRIES, LP - Northfield
| Recalling firm | Medline Industries, LP |
|---|---|
| Registered facility | View this company's 31 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| 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. |
| Product | Sterile surgical convenience kit: Medline Retrograde PK-22025203-LF, Pack #DYNJ47873L, containing a Pure Pouch with component Sterile Curved Kelly Hemostat, Reorder #66175. |
| Quantity | 12,588 total sterile kits |
| 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. |
| Initiated | 2024-03-14 |
| Classified | 2024-06-28 |
| Recall number | Z-2225-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — MEDLINE INDUSTRIES, LP - Northfield (Z-2225-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/94239/
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