FDA recall Z-2993-2024

Product

Medline Convenience kits labeled as: 1) CATH LAB SPECIAL PROCEDURE, Pack Number 00-RDF036O; 2) CATH LAB SPECIAL PROCEDURE, Pack Number 00-RDF036OH; 3) CATH ACCESSORY PACK, Pack Number 0M-CP31433J; 4) 3" RADIAL ARTERIAL LINE KIT- OR, Pack Number ART1210; 5) PERF. ASSOC. CUT DOWN TRAY, Pack Number BM17BAD; 6) CATHETER ADD A CATH TRAY, Pack Number CVI4970; 7) BIOPSY TRAY, Pack Number DYNDH1129; 8) ARTHROGRAM TRAY, Pack Number DYNDH1134; 9) BRISTOL MYELOGRAM, Pack Number DYNDH1228; 10) LUMBAR TRAY, Pack Number DYNDH1540A; 11) RADIOLOGY BASIC PACK, Pack Number DYNDH1827; 12) BLOOD CULTURE KIT W/BOTTLES, Pack Number DYNDH1932; 13) BIOPSY PACK, Pack Number DYNDL1462B; 14) CATH LAB PACK-LF, Pack Number DYNJ0105963Q; 15) CARDIAC CATH HARPER PACK-LF, Pack Number DYNJ0161912G; 16) CATH LAB PACK-LF, Pack Number DYNJ0173400P; 17) CATH LAB PACK-LF, Pack Number DYNJ0194968AG; 18) PICC LINE PACK-LF, Pack Number DYNJ0275614F; 19) PEDI CATH PACK-LF, Pack Number DYNJ0429201L; 20) SPE

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-2993-2024