Recall Z-1456-2025— MEDLINE INDUSTRIES, LP - Northfield
Class I · Ongoing
Class I FDA medical device recall by MEDLINE INDUSTRIES, LP - Northfield, initiated 2025-02-21. FDA's recall record names no specific 510(k) clearance for this event. Product: Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: CABG OPNHRT S HSP, CARDIAC CABG, CARDIAC PACK, DR D AC PACK, HEART BASIN PACK-LF, K OH COMPONENT PACK, OPEN HEART ADULT PART 1 CDS, OPEN HEART B PACK-LF, OPEN HEART PACK, Z OPEN HEART.. Reason: Medline medical procedure kits, containing Medtronic Aortic Root Cannula.
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2025-02-21
- Firm location
- Northfield, IL, United States
Product description
Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: CABG OPNHRT S HSP, CARDIAC CABG, CARDIAC PACK, DR D AC PACK, HEART BASIN PACK-LF, K OH COMPONENT PACK, OPEN HEART ADULT PART 1 CDS, OPEN HEART B PACK-LF, OPEN HEART PACK, Z OPEN HEART.
Reason for recall
Medline medical procedure kits, containing Medtronic Aortic Root Cannula
Data sourced from openFDA. This site is unofficial and independent of the FDA.