MEDLINE STERILE IRIS SCISSORS CVD/STD, REF DYNJ04049
Summary
The FDA issued a Class II for MEDLINE STERILE IRIS SCISSORS CVD/STD, REF DYNJ04049 by MEDLINE INDUSTRIES, LP - Northfield. Reason: 4.5" Iris Scissors, Sterile, Curved (DYNJ04049) are being recalled due to the potential of the tip protector to fall off. The sharp tip of the scissor.
Details
Source
Device Recall
External ID
Z-2595-2023
Action Date
2023-09-27
Status
Ongoing
Category
device
Product Description
MEDLINE STERILE IRIS SCISSORS CVD/STD, REF DYNJ04049
Lot/Code Info: UDI/DI 10080196847273, all lots
Quantity Affected: 324,451 devices
Reason for Recall
4.5" Iris Scissors, Sterile, Curved (DYNJ04049) are being recalled due to the potential of the tip protector to fall off. The sharp tip of the scissors could compromise the sterile barrier system by puncturing large and/or small holes that may not be visible to the user.
Distribution
Worldwide distribution: US (nationwide) and OUS (foreign) countries of: Canada, Hong Kong, Taiwan, Singapore
Type: Voluntary: Firm initiated
Recall Initiated: 2023-08-03
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 195 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-2595-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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