MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: a) OCULOPLASTY PACK, Model Number DYNJ64572A; b) EYE PAC
Summary
The FDA issued a Class II for MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: a) OCULOPLASTY P by MEDLINE INDUSTRIES, LP - Northfield. Reason: Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON-STERILE PVP SOLUTION, STERILE PACKAGING"..
Details
Source
Device Recall
External ID
Z-2136-2023
Action Date
2023-07-19
Status
Ongoing
Category
device
Product Description
MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: a) OCULOPLASTY PACK, Model Number DYNJ64572A; b) EYE PACK, Model Number VAL050EEPKB
Lot/Code Info: a) Model Number DYNJ64572A, UDI/DI (EA) 10195327112554, (CS) 40195327112555, Lot Numbers:23FBA458, 23DBC239 ; b) Model Number VAL050EEPKB, UDI/DI (EA) 10195327267149, (CS) 40195327267149, Lot Numbers: 23EBA381, 23CBI693, 23BBE528
Quantity Affected: 1500 units
Reason for Recall
Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON-STERILE PVP SOLUTION, STERILE PACKAGING".
Distribution
Worldwide distribution - US Nationwide and the country of Panama.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-05-18
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 165 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-2136-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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