Summary
The FDA issued a Class II for B L BIOTRU MULTI PURPOSE SOLUTION 4 FLOZ, SKU 999009 by Family Dollar Stores, Llc.. Reason: Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022..
Details
Source
Device Recall
External ID
Z-1531-2022
Action Date
2022-08-24
Status
Ongoing
Category
device
Product Description
B L BIOTRU MULTI PURPOSE SOLUTION 4 FLOZ, SKU 999009
Lot/Code Info: All product sold between May 1, 2022 - June 10, 2022.
Quantity Affected: 1051
Reason for Recall
Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.
Distribution
Product distributed to Family Dollar retail stores in US nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-06-23
Company
Chesapeake, VA
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 132 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Family Dollar Stores, Llc. has 149 FDA actions in our database, including 149 recalls.
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 (Family Dollar Stores, Llc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Family Dollar Stores, Llc. have FDA actions?
Family Dollar Stores, Llc. has 149 FDA actions in our database, including 149 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1531-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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