Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0009-05

Applied Blunt Tip Trocar Models C0717 and C0718

Applied Medical Resources Corp / initiated 2004-09-17 / Terminated

Applied Medical Resources Corp began a recall of Applied Blunt Tip Trocar Models C0717 and C0718 on . The reason FDA records is "Inadequate trocar tip assembly that might yeild parts to patients". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0009-05
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Applied Medical Resources Corp
Product
Applied Blunt Tip Trocar Models C0717 and C0718
Product code
KXN Monitor, Cardiac, Fetal
Reason for recall
Inadequate trocar tip assembly that might yeild parts to patients.
FDA root cause
Other
Action
Initiated recall by letter on 9/16/2004 via Fedex/UPS. Follow-up to nonresponders in 30 days.
Quantity in commerce
1025
Distribution
Nationwide. Ireland.
Product codes and lots
Trocars are assembled into procedure kits. Trocars have thier own serial number but the kit lots are relevant and include:  45036301001 to 45036301007 containing 1 each of lot 126803 = 71 each; 45208001001 to 452084001008 containing 1 each of lot 127322=8 each; 452451005001 to 452451005003 containing 1 each of lot 127322=3 each; 453029001001 to 453029001017 containing 1 each of lot 127322 = 17 each; 453715004002 containing 1 each of lot 126803 = 1 each; 454116005001 to 454116005002 containing 1 each of lot 127322 = 2; 454608003001 to 454608003006 containing 1 each of lot 172528 = 6 each.