FDA recall Z-2997-2024

Product

Medline Convenience kits labeled as: 1) PUNCTURE TRAY , Pack Number 00-401649G ; 2) PICC LINE TRAY, Pack Number 00-401993O ; 3) ARTERIOGRAM TRAY, Pack Number 00-402001T ; 4) ARTERIOGRAM TRAY, Pack Number 00-402001U ; 5) HEALTH LINE MAX BARRIER KIT , Pack Number A134-MAX ; 6) ART-LINE SURGERY PACK-LF, Pack Number ARTNC175 ; 7) AV FISTULA PACK , Pack Number CDS840188M ; 8) VP SHUNT, Pack Number CDS840193V ; 9) THROMBECTOMY/AV FISTULA CDS-LF, Pack Number CDS840295G ; 10) IVC PLACEMENT CDS-LF, Pack Number CDS860033A ; 11) IVC PLACEMENT CDS-LF, Pack Number CDS860033AH; 12) CENTRAL LINE CDS, Pack Number CDS930092V ; 13) CENTRAL LINE CDS, Pack Number CDS930092W ; 14) CENTRAL LINE CDS, Pack Number CDS930092X ; 15) C LINE INSERTION CDS, Pack Number CDS980379I ; 16) C LINE INSERTION CDS, Pack Number CDS980379J ; 17) AV FISTULA - SMH, Pack Number CDS980916L ; 18) AV FISTULA CDS, Pack Number CDS981513G ; 19) VASCULAR ACCESS CDS , Pack Number CDS981552F ; 20) VP SHUNT CDS, Pack

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.

Distribution

Worldwide distribution.

Key facts

Status

Ongoing

Initiation date

2024-04-08

Report date

2024-09-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2997-2024