ClearanceBrief
Recall Z-0009-05 ยท KXN Monitor, Cardiac, Fetal

Applied Medical Resources Corp

Applied Blunt Tip Trocar Models C0717 and C0718

DateOct 5, 2004 (initiated Sep 17, 2004)
StatusTerminated
ReasonInadequate trocar tip assembly that might yeild parts to patients.
Root causeOther
ActionInitiated recall by letter on 9/16/2004 via Fedex/UPS. Follow-up to nonresponders in 30 days.
Quantity1025
DistributionNationwide. Ireland.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K923636TROCAR W/ BLUNT TIP OBTURATOR
Applied Medical Resources, Nov 5, 1993