MEDLINE Polyurethane Bedside Cleaning Kit, REF DYK500FSAW
Summary
The FDA issued a Class II for MEDLINE Polyurethane Bedside Cleaning Kit, REF DYK500FSAW by MEDLINE INDUSTRIES, LP - Northfield. Reason: Sporadic reports were received of discoloration on the foam sponge on certain lots of the product, which has been identified as microbial contaminatio.
Details
Source
Device Recall
External ID
Z-1219-2022
Action Date
2022-06-08
Status
Ongoing
Category
device
Product Description
MEDLINE Polyurethane Bedside Cleaning Kit, REF DYK500FSAW
Lot/Code Info: DI: (01) 40888277367372; All Envirolite lot numbers which have the following format on individual packaging: YYMMDD X where YY is last 2 digits of Year of production, MM is the number of the month of production, DD is the day of production and X is the leading number of the raw material batch number.
Quantity Affected: 500 boxes of 100 units
Reason for Recall
Sporadic reports were received of discoloration on the foam sponge on certain lots of the product, which has been identified as microbial contamination.
Distribution
US and Panama
Type: Voluntary: Firm initiated
Recall Initiated: 2022-04-21
Company
Northfield, IL
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 184 device recalls issued in the same week, part of 413 device-related FDA actions this month.
MEDLINE INDUSTRIES, LP - Northfield has 822 FDA actions in our database, including 822 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 (MEDLINE INDUSTRIES, LP - Northfield) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does MEDLINE INDUSTRIES, LP - Northfield have FDA actions?
MEDLINE INDUSTRIES, LP - Northfield has 822 FDA actions in our database, including 822 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1219-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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