Recall Z-0165-2023— MEDLINE INDUSTRIES, LP - Northfield

Class II · Ongoing

Class II FDA medical device recall by MEDLINE INDUSTRIES, LP - Northfield, initiated 2022-09-30. FDA's recall record names no specific 510(k) clearance for this event. Product: MEDLINE RADIOLOGY PROCEDURE PACK, REF DYNJ67150A. Convenience kit used in medical procedures.. Reason: Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal..

Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Classification
Class II
Status
Ongoing
Initiated
2022-09-30
Firm location
Northfield, IL, United States

Product description

MEDLINE RADIOLOGY PROCEDURE PACK, REF DYNJ67150A. Convenience kit used in medical procedures.

Reason for recall

Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.

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