OnGuard2 CSTD Bag Adaptor SP A Chemfort CSTD Product, Product code MG412143
Summary
The FDA issued a Class II for OnGuard2 CSTD Bag Adaptor SP A Chemfort CSTD Product, Product code MG412143 by SIMPLIVIA HEALTHCARE LTD.. Reason: Disconnection of the OnGuard2 Bag Adaptor SP from infusion bags which may result in spillage of hazardous medications..
Details
Source
Device Recall
External ID
Z-1057-2022
Action Date
2022-05-18
Status
Ongoing
Category
device
Product Description
OnGuard2 CSTD Bag Adaptor SP A Chemfort CSTD Product, Product code MG412143
Lot/Code Info: UDI: 37290115921435, Lots: UBE507, UBE508, UBE513, UBE516, UBE517, UBE509, UBE511, UBE512, UBE514, UBE515, UBE517, UBE518, UBE526, UBE530, UBE531, UBE534, UBE533, UBE535, UBE536
Quantity Affected: 293,520
Reason for Recall
Disconnection of the OnGuard2 Bag Adaptor SP from infusion bags which may result in spillage of hazardous medications.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-03-08
Company
Kiryat Shmona, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 140 device recalls issued in the same week, part of 403 device-related FDA actions this month.
SIMPLIVIA HEALTHCARE LTD. has 5 FDA actions in our database, including 1 recall and 4 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (SIMPLIVIA HEALTHCARE LTD.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does SIMPLIVIA HEALTHCARE LTD. have FDA actions?
SIMPLIVIA HEALTHCARE LTD. has 5 FDA actions in our database, including 1 recall and 4 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1057-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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