CLASS II ONGOING Device recall · Reported 18 May 2022 · FDA Enforcement Report
OnGuard2 Cstd Bag Adaptor SP A Chemfort Cstd Product, Product recalled
Simplivia Healthcare is recalling OnGuard2 Cstd Bag Adaptor SP A Chemfort Cstd Product, Product, distributed nationwide in the US. The recall was initiated on 8 Mar 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1057-2022
- FDA event ID
- 89952
- Recalling firm
- Simplivia Healthcare, Kiryat Shmona, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 8 Mar 2022
- FDA classified
- 11 May 2022
- Reported
- 18 May 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 8 Mar 2022 | Recall initiated by company | |
| 11 May 2022 | Classified by FDA | +64 days |
| 18 May 2022 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Disconnection of the OnGuard2 Bag Adaptor SP from infusion bags which may result in spillage of hazardous medications.
Product as listed by the FDA
OnGuard2 CSTD Bag Adaptor SP A Chemfort CSTD Product, Product code MG412143
Where it was distributed
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.
Nationwide AlabamaArkansasArizonaCaliforniaColoradoConnecticutDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMaine
Questions about this recall
Is OnGuard2 Cstd Bag Adaptor SP A Chemfort Cstd Product, Product recalled?
Yes. Simplivia Healthcare recalled OnGuard2 Cstd Bag Adaptor SP A Chemfort Cstd Product, Product on 8 Mar 2022. The recall is Class II and its status is Ongoing. Recall number Z-1057-2022.
Why was it recalled?
Disconnection of the OnGuard2 Bag Adaptor SP from infusion bags which may result in spillage of hazardous medications.
Which lots are affected?
UDI: 37290115921435, Lots: UBE507, UBE508, UBE513, UBE516, UBE517, UBE509, UBE511, UBE512, UBE514, UBE515, UBE517, UBE518, UBE526, UBE530, UBE531, UBE534, UBE533, UBE535, UBE536
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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