Recall Z-1432-2024— MEDLINE INDUSTRIES, LP - Northfield

Class II · Ongoing

Class II FDA medical device recall by MEDLINE INDUSTRIES, LP - Northfield, initiated 2024-02-23. FDA's recall record names no specific 510(k) clearance for this event. Product: Centurion STERILE #5 LARYNGEAL MIRROR(505709), Product Code 67830. Reason: Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users..

Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Classification
Class II
Status
Ongoing
Initiated
2024-02-23
Firm location
Northfield, IL, United States

Product description

Centurion STERILE #5 LARYNGEAL MIRROR(505709), Product Code 67830

Reason for recall

Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.

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