Recall Z-1443-2025— MEDLINE INDUSTRIES, LP - Northfield
Class II · Ongoing
Class II FDA medical device recall by MEDLINE INDUSTRIES, LP - Northfield, initiated 2025-02-11. FDA's recall record names no specific 510(k) clearance for this event. Product: Medline procedure kits labeled as: 1) CV NEONATAL PACK, Pack Number DYNJ67356. Reason: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health..
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-02-11
- Firm location
- Northfield, IL, United States
Product description
Medline procedure kits labeled as: 1) CV NEONATAL PACK, Pack Number DYNJ67356
Reason for recall
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.
Data sourced from openFDA. This site is unofficial and independent of the FDA.