Recall Z-1459-2025— 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: CPB ADJUNCT PACK, DR. C PACK, PK CUST CV A&B C CO, TOL DR R PACK, TOL DR. C PACK, TOL DR. M PACK.. Reason: Medical convenience kits containing Medtronic Aortic Root Cannula are being recalled due to the potential excess material in the male lures on the aortic 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: CPB ADJUNCT PACK, DR. C PACK, PK CUST CV A&B C CO, TOL DR R PACK, TOL DR. C PACK, TOL DR. M PACK.
Reason for recall
Medical convenience kits containing Medtronic Aortic Root Cannula are being recalled due to the potential excess material in the male lures on the aortic cannula.
Data sourced from openFDA. This site is unofficial and independent of the FDA.