Recall Z-1646-2023— MEDLINE INDUSTRIES, LP - Northfield

Name: FDA recall Z-1646-2023
Creator: U.S. Food and Drug Administration
Published: 2023-04-21

Class II · Ongoing

Class II FDA medical device recall by MEDLINE INDUSTRIES, LP - Northfield, initiated 2023-04-21. FDA's recall record names no specific 510(k) clearance for this event. Product: Procedure packs: (1) Medline Sterile Arthroscopy Pack, REF: DYNJ64242B; (2) Medline Sterile Shoulder Pack, REF: DYNJ64250A; and (3) Medline Sterile Upper Extremity Pack, REF: DYNJ64253B.. Reason: The kits were damaged by water..

Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Classification: Class II
Status: Ongoing
Initiated: 2023-04-21
Firm location: Northfield, IL, United States

Product description

Procedure packs: (1) Medline Sterile Arthroscopy Pack, REF: DYNJ64242B; (2) Medline Sterile Shoulder Pack, REF: DYNJ64250A; and (3) Medline Sterile Upper Extremity Pack, REF: DYNJ64253B.

Reason for recall

The kits were damaged by water.

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