FDAClass IIMay 18, 2022

OnGuard2 CSTD Bag Adaptor SP A Chemfort CSTD Product recall

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

Why was OnGuard2 CSTD Bag Adaptor SP A Chemfort CSTD Product recalled?

Disconnection of the OnGuard2 Bag Adaptor SP from infusion bags which may result in spillage of hazardous medications.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI: 37290115921435, Lots: UBE507, UBE508, UBE513, UBE516, UBE517, UBE509, UBE511, UBE512, UBE514, UBE515, UBE517, UBE518, UBE526, UBE530, UBE531, UBE534, UBE533, UBE535, UBE536

Product
OnGuard2 CSTD Bag Adaptor SP A Chemfort CSTD Product, Product code MG412143
Recalling firm
SIMPLIVIA HEALTHCARE LTD.
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.
Recall date
May 18, 2022
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls