Chemotherapy Infusion Bag Adaptor May Disconnect and Spill Hazardous Drugs
Simplivia Healthcare is recalling OnGuard2 CSTD Bag Adaptors because they may disconnect from infusion bags, potentially spilling hazardous medications.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device with potential for hazardous medication spillage. The hazard is based on product failure (disconnection) risking drug exposure, which qualifies as a risk-of-harm scenario. No illnesses or injuries are documented in the source material, supporting a High severity rating.
Plain-English summary
Simplivia Healthcare Ltd. is recalling the OnGuard2 CSTD Bag Adaptor SP A Chemfort CSTD Product (Product code MG412143) because the adaptor may disconnect from infusion bags, which could result in spillage of hazardous medications.
Affected lots include UBE507, UBE508, UBE509, UBE511, UBE512, UBE513, UBE514, UBE515, UBE516, UBE517, UBE518, UBE526, UBE530, UBE531, UBE533, UBE534, UBE535, and UBE536. Approximately 293,520 units were distributed nationwide across all US states.
Healthcare providers using affected adaptors should immediately stop use and contact Simplivia Healthcare Ltd. for instructions regarding replacement or return of the product.
The recalled product
- Product
- OnGuard2 CSTD Bag Adaptor SP A Chemfort CSTD Product, Product code MG412143
- Manufacturer
- SIMPLIVIA HEALTHCARE LTD.
- Affected units
- 293,520
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (19)
- UDI: 37290115921435
- Lots: UBE507
- UBE508
- UBE513
- UBE516
- UBE517
- UBE509
- UBE511
- UBE512
- UBE514
- UBE515
- UBE518
- UBE526
- UBE530
- UBE531
- UBE534
- UBE533
- UBE535
- UBE536
Distribution
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