OnGuard2 CSTD Bag Adaptor SP A Chemfort CSTD Product… recallZ-1057-2022 · Simplivia Healthcare Ltd. · initiated Mar 8, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Simplivia Healthcare Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Disconnection of the OnGuard2 Bag Adaptor SP from infusion bags which may result in spillage of hazardous medications.
FDA root cause category: Equipment maintenance
What the company is doing
The recall notice and acknowledgement form dated 08 March 2022 were sent under B. Braun cover letter on 03/10/2022 via Certified USPS mail. Distributors are to forward the recall notification to customers to extend the recall to the end user/customer level. Identify current inventory, cease use and quarantine product subject to recall. Do not destroy, return product and complete the Product Removal Acknowledgement form. If you are a direct consignee of B. Braun Medical Inc. a B. Braun customer service representative will contact you to arrange for return of product. If you have received this recall notice from a customer of B. Braun, please return product to your local distributor to ensure proper credit and replacement of material. OnGuard Spike Port Adaptor may be used as an alternative to replace the OnGuard2 Bag Adaptor SP. If you have questions contact Simplivia: Shay Shaham, Sunday to Friday, 08:00 to 19:00 (GMT+2) at the following phone number: 97246908826.
Recall details
- Recall number
- Z-1057-2022
- Status
- Open, Classified
- Initiated by the company
- Mar 8, 2022
- Recalling firm
- Simplivia Healthcare Ltd.
- Quantity
- 293,520
- Product code
- ONB
- FDA submissions
- K192866
- 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.
Product description
OnGuard2 CSTD Bag Adaptor SP A Chemfort CSTD Product, Product code MG412143
Code information (models, lots, serial numbers)
UDI: 37290115921435, Lots: UBE507, UBE508, UBE513, UBE516, UBE517, UBE509, UBE511, UBE512, UBE514, UBE515, UBE517, UBE518, UBE526, UBE530, UBE531, UBE534, UBE533, UBE535, UBE536
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- OnGuard®2 CSTD Bag Adaptor SP 412143Simplivia Healthcare Ltd · Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System1 recall43 reports
Other devices under the same FDA submission
1 device cleared under K192866 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- OnGuard®2 CSTD Syringe Adaptor 412163Simplivia Healthcare Ltd · Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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