Recall Z-1121-2023— MEDLINE INDUSTRIES, LP - Northfield

Class II · Ongoing

Class II FDA medical device recall by MEDLINE INDUSTRIES, LP - Northfield, initiated 2022-12-07. FDA's recall record names no specific 510(k) clearance for this event. Product: Surgical convenience kits labeled as: MEDLINE LCPH LAB DRAW KIT, Reorder Number DYNDH1641A. Reason: The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile..

Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Classification
Class II
Status
Ongoing
Initiated
2022-12-07
Firm location
Northfield, IL, United States

Product description

Surgical convenience kits labeled as: MEDLINE LCPH LAB DRAW KIT, Reorder Number DYNDH1641A

Reason for recall

The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.

Data sourced from openFDA. This site is unofficial and independent of the FDA.