MEDLINE LUER SLIP DISPOSABLE SYRINGE WITHOUT NEEDLE, REF SYR101020
Summary
The FDA issued a Class II for MEDLINE LUER SLIP DISPOSABLE SYRINGE WITHOUT NEEDLE, REF SYR101020 by MEDLINE INDUSTRIES, LP - Northfield. Reason: It has been identified that testing documentation does not support that the syringes can successfully deliver accurate volumes across the full range o.
Details
Source
Device Recall
External ID
Z-1938-2024
Action Date
2024-06-12
Status
Ongoing
Category
device
Product Description
MEDLINE LUER SLIP DISPOSABLE SYRINGE WITHOUT NEEDLE, REF SYR101020
Lot/Code Info: UDI/DI 10080196306183, All lots in the format: 897YYMMXXXX
Quantity Affected: 5,075,234 syringes
Reason for Recall
It has been identified that testing documentation does not support that the syringes can successfully deliver accurate volumes across the full range of their claimed graduated capacity and may pose a risk to patient health.
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Panama, UAE, USVI.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-04-22
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 212 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-1938-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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