MEDLINE PHERIPHERAL BLOOD CULTURE DRAW, Reorder #: DYNDH1561
Summary
The FDA issued a Class II for MEDLINE PHERIPHERAL BLOOD CULTURE DRAW, Reorder #: DYNDH1561 by MEDLINE INDUSTRIES, LP - Northfield. Reason: Adult Blood Culture Collect kit and Pre-Op Changing Bathing Kit contain an incorrect expiration date on a component with the kit. CHG Solution with th.
Details
Source
Device Recall
External ID
Z-0121-2023
Action Date
2022-11-02
Status
Ongoing
Category
device
Product Description
MEDLINE PHERIPHERAL BLOOD CULTURE DRAW, Reorder #: DYNDH1561
Lot/Code Info: UDI/DI: (01)40193489402811 (case), (01)10193489402810 (kit), Lot Number 22FMF307
Quantity Affected: 1020 kits
Reason for Recall
Adult Blood Culture Collect kit and Pre-Op Changing Bathing Kit contain an incorrect expiration date on a component with the kit. CHG Solution with the Pre-Op Changing Bathing Kit and Bactec bottle plastic both have an expiration date that does not match the date listed on the kit.
Distribution
US Nationwide distribution in the state of California.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-09-09
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 128 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-0121-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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