Recall Z-3010-2024— MEDLINE INDUSTRIES, LP - Northfield

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) CVC INSERTION PACK, Pack Number CVI4720A ; 2) CVC INSERTION PACK, Pack Number CVI4720AH; 3) CATHETER INSERTION KIT CLABSI , Pack Number CVI4880; 4) CHEST INSERTION PACK-LF , Pack Number DYNJ17634D ; 5) URETEROSCOPY, Pack Number DYNJ45882A ; 6) TONSIL PACK CATH, Pack Number DYNJ65199A ; 7) CATH PLACEMENT RIB FRACTURE , Pack Number DYNJ66475B ; 8) UROLOGY ROBOTIC PACK, Pack Number DYNJ80211C ; 9) UROLOGY ROBOTIC PACK, Pack Number DYNJ80211CH; 10) UROLOGY PK, Pack Number DYNJ80252C ; 11) PORT INSERTION PACK , Pack Number DYNJ81597. 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

Data sourced from openFDA. This site is unofficial and independent of the FDA.