Z-1057-2022Class II

OnGuard2 CSTD Bag Adaptor SP A Chemfort CSTD Product, Product code MG412143

Name: Z-1057-2022 OnGuard2 CSTD Bag Adaptor SP A Chemfort CSTD Product, Product code MG412143
Creator: Simplivia Healthcare Ltd.
Published: 2022-03-08
License: https://open.fda.gov/license/

Simplivia Healthcare Ltd. / initiated 2022-03-08 / Open, Classified / root cause: manufacturing process

FDA source

SIMPLIVIA HEALTHCARE LTD. began a recall of OnGuard2 CSTD Bag Adaptor SP A Chemfort CSTD Product, Product code MG412143 on 2022-03-08. FDA classified it as Class II and gives the reason as "Disconnection of the OnGuard2 Bag Adaptor SP from infusion bags which may result in spillage of hazardous medications". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1057-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-03-08
Posted: 2022-05-11
Recalling firm: Simplivia Healthcare Ltd.
Product: OnGuard2 CSTD Bag Adaptor SP A Chemfort CSTD Product, Product code MG412143
Product code: ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
Reason for recall: Disconnection of the OnGuard2 Bag Adaptor SP from infusion bags which may result in spillage of hazardous medications.
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: 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.
Quantity in commerce: 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.
Product codes and lots: UDI: 37290115921435, Lots: UBE507, UBE508, UBE513, UBE516, UBE517, UBE509, UBE511, UBE512, UBE514, UBE515, UBE517, UBE518, UBE526, UBE530, UBE531, UBE534, UBE533, UBE535, UBE536

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1057-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1057-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-05-18	2022-05-11

Product code ONB

K192866Class IIChemfort CSTDSimplivia Healthcare , Ltd. / cleared 2020-05-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)