Class II — SIMPLIVIA HEALTHCARE LTD.
| Recalling firm | SIMPLIVIA HEALTHCARE LTD. |
|---|---|
| Registered facility | SIMPLIVIA HEALTHCARE LTD. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Disconnection of the OnGuard2 Bag Adaptor SP from infusion bags which may result in spillage of hazardous medications. |
| Product | OnGuard2 CSTD Bag Adaptor SP A Chemfort CSTD Product, Product code MG412143 |
| Quantity | 293,520 |
| Distribution | Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY. |
| Initiated | 2022-03-08 |
| Classified | 2022-05-11 |
| Recall number | Z-1057-2022 |
| 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 — SIMPLIVIA HEALTHCARE LTD. (Z-1057-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/89952/
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