Medical Device Recall: Z-0009-05

FDA Recalls dataset · Firm: Applied Medical Resources Corp 22872 Avenida Empresa # 3 Rancho Santa · Status: Terminated

Recall Action Class: N/A Date Initiated: 2004-09-17 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0009-05.

Recall Res Number
Z-0009-05
FEI Number
2027111
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2004-09-17
Date Posted
2004-10-05
Date Terminated
2005-08-05
Product Code
KXN
Event Number
30036
Product Quantity
1025
Product Description Applied Blunt Tip Trocar Models C0717 and C0718
Reason for Recall Inadequate trocar tip assembly that might yeild parts to patients.
Action Details Initiated recall by letter on 9/16/2004 via Fedex/UPS. Follow-up to nonresponders in 30 days.
Distribution Pattern Nationwide. Ireland.
Code Information / Serial Numbers 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.

Related Establishments / Registrations

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