Recall Z-0122-2025— MEDLINE INDUSTRIES, LP - Northfield
Class II · Ongoing
Class II FDA medical device recall by MEDLINE INDUSTRIES, LP - Northfield, initiated 2024-08-28. FDA's recall record names no specific 510(k) clearance for this event. Product: MEDLINE OPEN HEART, REF DYNJ904261B. Reason: Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the DLP Vessel Cannulae. During manufacturing of the three listed lot numbers, product for model 30001 was incorrectly labeled as model 30000..
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-08-28
- Firm location
- Northfield, IL, United States
Product description
MEDLINE OPEN HEART, REF DYNJ904261B
Reason for recall
Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the DLP Vessel Cannulae. During manufacturing of the three listed lot numbers, product for model 30001 was incorrectly labeled as model 30000.
Data sourced from openFDA. This site is unofficial and independent of the FDA.