Summary
The FDA issued a Class II for 24 BLOOD CULTURE KIT, REF DYNDH1632 by MEDLINE INDUSTRIES, LP - Northfield. Reason: This recall is being issued due to items within the kit have expired prior to the overall kit expiration date listed on the insert..
Details
Source
Device Recall
External ID
Z-0313-2024
Action Date
2023-11-22
Status
Ongoing
Category
device
Product Description
24 BLOOD CULTURE KIT, REF DYNDH1632
Lot/Code Info: UDI/DI 40193489916141 (case), 10193489916140 (unit): Lot Numbers: 23EMF710, 23DMF154, 23DMA779
Quantity Affected: 3160 kits
Reason for Recall
This recall is being issued due to items within the kit have expired prior to the overall kit expiration date listed on the insert.
Distribution
US Nationwide distribution in the state of California.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-11-01
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 200 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-0313-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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