FDAClass IIJanuary 8, 2025

Medline custom medical procedure kits labeled as: 1) recall: Endotoxin

Medline custom medical procedure kits labeled as: 1) MICRODISECTOMY PACK, REF DYNJ80585A; 2) MICRODISECTOMY PACK, REF DYNJ80585B.

Why was Medline custom medical procedure kits labeled as: 1) recalled?

Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.

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?

1) REF DYNJ80585A, UDI/DI 10195327063948 (EA) 40195327063949 (CS), Lot Numbers: 22ABF513, 22DBK159, 22DBL699, 22FBQ597; 2) REF DYNJ80585B, UDI/DI 10195327211158 (EA), 40195327211159 (CS), Lot Numbers: 22GBV101, 22HBG177, 22HBU871, 23ABD760, 23BBE037, 23GBL753, 23GBV443, 23HBU815, 23IBJ525, 23JBO457, 23LBD006, 24BBC495, 24CBI323, 24DBJ068, 24DBP653, 24EBP712, 24FBM276, 24IBG473.

Product
Medline custom medical procedure kits labeled as: 1) MICRODISECTOMY PACK, REF DYNJ80585A; 2) MICRODISECTOMY PACK, REF DYNJ80585B.
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
1494 units
Distribution
Worldwide distribution - US Nationwide and the countries of UAE, and Canada.
Recall date
January 8, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls