FDA recall Z-2772-2024

Product

Centurion procedure kits, labeled as: 1) ARTHROGRAM TRAY, Pack Number DYNDH1349; 2) ARTHROGRAM TRAY-LF, Pack Number SPEC0400; 3) ARTHROGRAM/LP/MYELOGRAM TRAY, Pack Number PT220; 4) BIOPSY KIT, Pack Number DYNDH1570; 5) BIOPSY TRAY-LF, Pack Number SPEC4380; 6) BMA BX TRAY, Pack Number DYNDH1050A; 7) BREAST BIOPSY TRAY, Pack Number SPEC0130C; 8) CATHETER ON/OFF KIT, Pack Number DT5490B; 9) CDP, INTRODUCER KIT 9F, Pack Number S5078BF09; 10) CHEST TUBE INSERTION TRAY, Pack Number CHT705; 11) CIRCUMCISION TRAY, Pack Number CIT6260; 12) CUSTOM BIOPSY TRAY, Pack Number MNS4815; 13) DELIVERY ACCESSORY KIT, Pack Number MNS6496; 14) DELIVERY PACK, Pack Number MNS2925A; 15) DELIVERY PACK, Pack Number MNS2925B; 16) E. R. LACERATION TRAY, Pack Number DYNDL1187A; 17) FINE LACERATION KIT, Pack Number SUT19360; 18) GENERAL BIOPSY TRAY- LF, Pack Number SPEC0248B; 19) GENERAL UTILITY, Pack Number DYNDA2524; 20) HOLSTON MYELOGRAM PACK, Pack Number DYNDH1227A; 21

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-2772-2024