Recall Z-3001-2024— 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) ZALE STEREOTACTIC CDS , Pack Number CDS983173G ; 2) ZALE OTOLOGY CDS, Pack Number CDS983181D ; 3) BGMC GENERAL LAPAROSCOPY PK-LF, Pack Number DYNJ0664747A ; 4) NC3G MEDIASTINOSCOPY PACK-LF, Pack Number DYNJ0796243D ; 5) MEDIASTINOSCOPY PACK-LF , Pack Number DYNJ0796243F ; 6) RHINOPLASTY PACK, Pack Number DYNJ27333F ; 7) OSC OTOLOGY PACK-LF , Pack Number DYNJ37384C ; 8) OSC OTOLOGY PACK-LF , Pack Number DYNJ37384D ; 9) RHINO PACK, Pack Number DYNJ46504A ; 10) RHINO PACK, Pack Number DYNJ46504B ; 11) MEDIASTINOSCOPY TEGH-LF , Pack Number DYNJ46741B ; 12) PACEMAKER PACK, Pack Number DYNJ49787A ; 13) NASAL AND SINUS PACK, Pack Number DYNJ50425A ; 14) MSC SEPTO RHINO PACK-LF , Pack Number DYNJ51677A ; 15) MSC SEPTO RHINO PACK-LF , Pack Number DYNJ51677B ; 16) SEPTO RHINO PACK, Pack Number DYNJ53076C ; 17) PLASTIC ENT PACK - NTSC , Pack Number DYNJ54901A ; 18) RHINO/SEPTO/FESS PACK , Pack Number DYNJ55955B ; 19) RHINO/SEPTO/FESS PACK , Pack Number DYNJ55955C ; 20) MEDIASTINOSCOPY PACK, Pack Number DYNJ60872B ; 21) NOSE ESC, Pack Number DYNJ62371A ; 22) NASAL PACK, Pack Number DYNJ67789A ; 23) LOU MAJOR ENT , Pack Number DYNJ901851D; 24) LOU MINOR ENT , Pack Number DYNJ901852C; 25) RHYZOTOMY , Pack Number DYNJ902288G; 26) CHS NASAL AND SINUS PACK, Pack Number DYNJCH501. 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.