Medline O.R. Scissors, S/B, Sterile, 5.5, Model #DYND04000
Summary
The FDA issued a Class II for Medline O.R. Scissors, S/B, Sterile, 5.5, Model #DYND04000 by MEDLINE INDUSTRIES, LP - Northfield. Reason: The scissors were manufactured without a tip protector resulting in the scissors breaking through the semi-rigid plastic tray compromising sterility..
Details
Source
Device Recall
External ID
Z-2206-2023
Action Date
2023-07-26
Status
Ongoing
Category
device
Product Description
Medline O.R. Scissors, S/B, Sterile, 5.5, Model #DYND04000
Lot/Code Info: Lot numbers and UDI numbers: 23BBI031, 01100801968242291023BBI031; 23BBK353, 01100801968242291023BBK353; 23BBP830, 01100801968242291023BBP830; 23BBQ676, 01100801968242291023BBQ676; 23BBR546, 01100801968242291023BBR546; 23CBH009, 01100801968242291023CBH009; 23CBL930, 01100801968242291023CBL930; 23CBP165, 01100801968242291023CBP165; 23BBS369, 01100801968242291023BBS369; 23BBT718, 01100801968242291023BBT718; 23CBV064, 01100801968242291023CBV064; 23CBW834, 01100801968242291023CBW834; 23CBV222, 01100801968242291023CBV222; 23CBW020, 01100801968242291023CBW020; and 23CBQ190, 01100801968242291023CBQ190.
Quantity Affected: 189,221 scissors
Reason for Recall
The scissors were manufactured without a tip protector resulting in the scissors breaking through the semi-rigid plastic tray compromising sterility.
Distribution
US Nationwide distribution. There was government distribution but no military or foreign distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-05-12
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 192 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-2206-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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