Recall Z-2996-2024— MEDLINE INDUSTRIES, LP - Northfield
Class II · Ongoing
Class II FDA medical device recall by MEDLINE INDUSTRIES, LP - Northfield, initiated 2024-04-08. FDA's recall record names no specific 510(k) clearance for this event. Product: Medline Convenience kits labeled as: 1) DIALYSIS CATHETER INSERTION KIT, Pack Number CVI4815; 2) ANGIO PACK, Pack Number CVI5045; 3) CHILDRENS INFANT SP TRAY, Pack Number DYNDA2906; 4) ULTRASOUND GUIDE BREAST BIOPSY, Pack Number DYNDH1319; 5) BIOPSY TRAY, Pack Number DYNDH1693A; 6) PACK,ULTRASOUND, Pack Number DYNDL1461; 7) LUMBAR PUNCTURE TRAY, Pack Number DYNJTS4306; 8) ARTHROGRAM TRAY, Pack Number SPEC0143A; 9) PD CATH KIT, Pack Number UVT1205. 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
- 2024-04-08
- Firm location
- Northfield, IL, United States
Product description
Medline Convenience kits labeled as: 1) DIALYSIS CATHETER INSERTION KIT, Pack Number CVI4815; 2) ANGIO PACK, Pack Number CVI5045; 3) CHILDRENS INFANT SP TRAY, Pack Number DYNDA2906; 4) ULTRASOUND GUIDE BREAST BIOPSY, Pack Number DYNDH1319; 5) BIOPSY TRAY, Pack Number DYNDH1693A; 6) PACK,ULTRASOUND, Pack Number DYNDL1461; 7) LUMBAR PUNCTURE TRAY, Pack Number DYNJTS4306; 8) ARTHROGRAM TRAY, Pack Number SPEC0143A; 9) PD CATH KIT, Pack Number UVT1205
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.