FDAClass IIJanuary 8, 2025

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

Medline custom medical procedure kits labeled as: 1) CERVICAL PACK-LF, REF DYNJ0867145G; 2) CERVICAL SPINE PACK HUM-LF, REF DYNJ35184F; 3) ANTERIOR…

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 DYNJ0867145G, UDI/DI 10889942625413 (EA) 40889942625414 (CS), Lot Numbers: 19BDA435, 19DDD135; 2) REF DYNJ35184F, UDI/DI 10889942567737 (EA) 40889942567738 (CS), Lot Numbers: 19CBC965, 19QBC217; 3) REF DYNJ904827, UDI/DI 10889942743742 (EA) 40889942743743 (CS), Lot Numbers: 19DBD844, 19HBO089, 19HBQ573, 19IBQ930, 19SBE329.

Product
Medline custom medical procedure kits labeled as: 1) CERVICAL PACK-LF, REF DYNJ0867145G; 2) CERVICAL SPINE PACK HUM-LF, REF DYNJ35184F; 3) ANTERIOR…
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
182 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