MEDLINE INDUSTRIES, LP - Northfield: Medical Device Recall in 2024 - (Recall #: Z-3001-2024)

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

Class II

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.

CDS983173G , Lot Number 21FBQ527 ; CDS983173G , Lot Number 21HBF657 ; CDS983173G , Lot Number 21IBE910 ; CDS983173G , Lot Number 21IBM809 ; CDS983173G , Lot Number 21JBJ185 ; CDS983173G , Lot Number 21KBM498 ; CDS983173G , Lot Number 22ABF773 ; CDS983173G , Lot Number 22BBH011 ; CDS983173G , Lot Number 19ABX210 ; CDS983173G , Lot Number 22OBM500 ; CDS983173G , Lot Number 22EBQ566 ; CDS983173G , Lot Number 19GBS147 ; CDS983173G , Lot Number 19IBG146 ; CDS983173G , Lot Number 19IBJ785 ; CDS983173G , Lot Number 19KBA219 ; CDS983173G , Lot Number 19KBA926 ; CDS983173G , Lot Number 20BBA113 ; CDS983173G , Lot Number 20CBP609 ; CDS983173G , Lot Number 20DBU576 ; CDS983173G , Lot Number 20HBQ718 ; CDS983173G , Lot Number 20KBY137 ; CDS983173G , Lot Number 20LBL243 ; CDS983173G , Lot Number 21BBO662 ; CDS983173G , Lot Number 21EBC912 ; CDS983181D , Lot Number 21FBP606 ; CDS983181D , Lot Number 21FBP608 ; CDS983181D , Lot Number 21GBM695 ; CDS983181D , Lot Number 21IBW768 ; CDS983181D , Lot Number 21KBT227 ; 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Worldwide distribution.

Voluntary: Firm initiated