Recall Z-1110-2023— MEDLINE INDUSTRIES, LP - Northfield

Name: FDA recall Z-1110-2023
Creator: U.S. Food and Drug Administration
Published: 2022-12-07

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 ANGIO PORT KIT W/HIGH GRADE IN, Reorder Number DYNDC2691. 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 ANGIO PORT KIT W/HIGH GRADE IN, Reorder Number DYNDC2691

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.