FDA-Device2024-09-18Class II
Medline Convenience kits labeled as: 1) INFECTION DRIVELINE MANAGEMENT KIT, Pack Number DM645; 2) PICU LINE TRAY, Pack Number DYNDC1960A; 3) ULTRASOUND GUIDE BREAST BIOPSY, Pack Number DYNDH1319; 4) MINI INTERVENTIONAL PACK, Pack Number DYNDH1324A; 5) BONE MARROW BIOPSY ASPIRATION, Pack Number DYNDH1514; 6) BIOPSY KIT, Pack Number DYNDH1570; 7) MYELOGRAM TRAY, Pack Number DYNDH1574; 8) BONE MARROW ASPIRATION AND BIOPSY, Pack Number DYNDH1596; 9) BONE MARROW BIOPSY ASPIRATION,
MEDLINE INDUSTRIES, LP - Northfield
Hazard
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.
Sold states
Worldwide distribution.
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
Medline Convenience kits labeled as: 1) INFECTION DRIVELINE MANAGEMENT KIT, Pack Number DM645; 2) PICU LINE TRAY, Pack Number DYNDC1960A; 3) ULTRASOUND GUIDE BREAST BIOPSY, Pack Number DYNDH1319; 4) MINI INTERVENTIONAL PACK, Pack Number DYNDH1324A; 5) BONE MARROW BIOPSY ASPIRATION, Pack Number DYNDH1514; 6) BIOPSY KIT, Pack Number DYNDH1570; 7) MYELOGRAM TRAY, Pack Number DYNDH1574; 8) BONE MARROW ASPIRATION AND BIOPSY, Pack Number DYNDH1596; 9) BONE MARROW BIOPSY ASPIRATION, Pack Number DYNDH1638; 10) BIOPSY PACK, Pack Number DYNDH1699; 11) LACERATION TRAY, Pack Number DYNDL1159B; 12) SUTURE TRAY, Pack Number DYNDS1064B; 13) BONE MARROW BIOPSY ASPIRATION, Pack Number DYNJTS0214; 14) LUMBAR PUNCTURE TRAY, Pack Number DYNJTS4306; 15) PEDI ULTRASOUND GUIDED PIV KIT, Pack Number IVS3320; 16) ARTHROGRAM PACK, Pack Number P241108; 17) PACK BONE MARROW BIOPSY, Pack Number P268481; 18) BIOPSY BASIC PACK, Pack Number P784604; 19) ARTHROGRAM TRAY-LF, Pack Number SPEC0061B; 20) BIOPSY TRAY, Pack Number SPEC0095; 21) RADIOLOGY/BIOPSY, Pack Number SPEC0149; 22) BONE MARROW TRAY, Pack Number SPEC0255; 23) ARTHROGRAM TRAY-LF, Pack Number SPEC0400
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3029-2024Don't want to check this manually?
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