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U.S. Department of Health and Human Services

Class 2 Device Recall Applied Premium Disposable Blunt Tip Trocar System

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  Class 2 Device Recall Applied Premium Disposable Blunt Tip Trocar System see related information
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
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