Medline brand recall: Endotoxin
Medline brand, medical procedure convenience kits, labeled as: 1) MVFF/FIBU #54-RF , SKU DYNJ21927R; 2) DIEP FLAP, SKU DYNJ910120A
Why was Medline brand recalled?
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
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Medline brand, medical procedure convenience kits, labeled as: 1) MVFF/FIBU #54-RF , SKU DYNJ21927R; 2) DIEP FLAP, SKU DYNJ910120A
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 318 kits
- Distribution
- US Nationwide. Canada.
- Recall date
- January 1, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)