ClearanceBrief
Recall Z-0130-05 ยท FMI Needle, Hypodermic, Single Lumen

Kendall Healthcare Products Co

Curity Amniocentesis Tray with Safety Components Product Number: 97051

DateNov 2, 2004 (initiated Oct 8, 2004)
StatusTerminated
ReasonNeedle cannula may separate from the hub during use
Root causeOther
ActionRecall letters requesting product return were mailed to all customers on October 8, 2004
DistributionNationwide
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K012736MONOJECT SAFETY NEEDLE
Tyco Healthcare, Oct 25, 2001