Date Initiated by Firm |
September 17, 2004 |
Date Posted |
October 05, 2004 |
Recall Status1 |
Terminated 3 on August 05, 2005 |
Recall Number |
Z-0009-05 |
Recall Event ID |
30036 |
510(K)Number |
k923636
|
Product Classification |
Monitor, Cardiac, Fetal - Product Code KXN
|
Product |
Applied Blunt Tip Trocar
Models C0717 and C0718 |
Code Information |
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. |
Recalling Firm/ Manufacturer |
Applied Medical Resources Corp 22872 Avenida Empresa # 3 Rancho Santa Margarita CA 92688-2650
|
For Additional Information Contact |
mary Jo Stegwell 949-713-8000
|
Manufacturer Reason for Recall |
Inadequate trocar tip assembly that might yeild parts to patients.
|
FDA Determined Cause 2 |
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. |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = KXN and Original Applicant = APPLIED MEDICAL RESOURCES
|