Medline brand, medical procedure convenience kits, labeled as: 1) MVFF/FIBU #54-RF , SKU DYNJ21927R; 2) DIEP FLAP, SKU
Summary
The FDA issued a Class II for Medline brand, medical procedure convenience kits, labeled as: 1) MVFF/FIBU #54- by MEDLINE INDUSTRIES, LP - Northfield. Reason: Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within t.
Details
Source
Device Recall
External ID
Z-0721-2025
Action Date
2025-01-01
Status
Ongoing
Category
device
Product Description
Medline brand, medical procedure convenience kits, labeled as: 1) MVFF/FIBU #54-RF , SKU DYNJ21927R; 2) DIEP FLAP, SKU DYNJ910120A
Lot/Code Info: UDI-DI: DYNJ21927R, 10195327104733(each), 40195327104734(case); Lot Number: 23IBF547 23GBT501 23FBU360 23EBU929 23EBL624 23EBA114 23CBN730 23ABF393 22JBK203 22IBN858 22HBO301 22GBC794 22CBI774; UDI-DI: DYNJ910120A, 10195327689872 (each), 40195327689873 (case), Lot Numbers: 24HMK254
Quantity Affected: 318 kits
Reason for Recall
Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods
Distribution
US Nationwide. Canada.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-11-06
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 119 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-0721-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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