FDA recall Z-2768-2024

Product

Centurion procedure kits labeled as: 1) 3" RADIAL ARTERIAL LINE KIT- ICU, Pack Number ART240B; 2) 5FR 2L PICC LINE TRAY, Pack Number PICC0020; 3) 6" FEMORAL ARTERIAL LINE KIT, Pack Number ART245B; 4) ADVANCED REPAIR KIT, Pack Number SUT15940; 5) ARTHROGRAM TRAY, Pack Number SPEC0004C; 6) ARTHROGRAM TRAY, Pack Number DYNDH1134; 7) ARTHROGRAM TRAY-LF, Pack Number SPEC0400; 8) ARTHROGRAM/LP/MYELOGRAM TRAY, Pack Number PT220; 9) AULTMAN HOSPITAL CHEST TUBE INSERTION TR, Pack Number CHT500; 10) BIOPSY BASIC PACK, Pack Number P784604; 11) BIOPSY KIT, Pack Number DYNDA1466A; 12) BIOPSY SKIN/LACERATION TRAY, Pack Number SUT20455; 13) BIOPSY TRAY, Pack Number BT1015; 14) BIOPSY TRAY, Pack Number DYNDH1273; 15) BIOPSY TRAY, Pack Number BT1060; 16) BIOPSY TRAY, Pack Number DYNDH1340; 17) BIOPSY TRAY, Pack Number P151659; 18) BIOPSY TRAY, Pack Number SPEC0292; 19) BIOPSY TRAY, Pack Number DYNDH1314A; 20) BIOPSY TRAY, Pack Number DYNDH1137C; 21) BIOPSY TRAY - LF, Pack Number

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

Key facts

Status

Ongoing

Initiation date

2024-04-08

Report date

2024-09-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2768-2024