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Class 2 Device Recall 15mm Separator Access System |
![see related information](../images/related-info.gif) |
Date Initiated by Firm |
June 25, 2008 |
Date Posted |
October 07, 2008 |
Recall Status1 |
Terminated 3 on March 26, 2012 |
Recall Number |
Z-0023-2009 |
Recall Event ID |
49445 |
510(K)Number |
K945741 K012884
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Product Classification |
laparoscopic trocar - Product Code HET
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Product |
Applied Medical, Separator Abdominal Access System REF: C0604 15 x 100mm Non-threaded Separator System with Universal Seal, for laparoscopic procedures. |
Code Information |
Product/Kit Batch Numbers: 1061480, 1061127, 1060184, 1058796, 1058108, 1056578, 1056709, 1054094, 1054837 |
Recalling Firm/ Manufacturer |
Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa Margarita CA 92688
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For Additional Information Contact |
949-713-8000
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Manufacturer Reason for Recall |
Potential inability to insufflate through the stopcock. Under certain circumstances, a flexible elastomeric component inside the 15mm trocar can
stretch into a configuration that blocks the flow of insufflation gas (C02).
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FDA Determined Cause 2 |
Process control |
Action |
Customers were notified via FedEx or UPS on June 25,2008 with an overnight letter. The letter advises that Applied Medical is conducting a voluntary recall of the 15mm Separator Access Systems, Models C0604, C0605, C0606 and C0607 due to the potential inability to insufflate through the stopcock. Per the letter, the firm is asking
that all 15mm product listed in the letter be returned. A response form is provided. |
Quantity in Commerce |
14,113 total |
Distribution |
Nationwide and Canada distribution. |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = HET and Original Applicant = APPLIED MEDICAL RESOURCES 510(K)s with Product Code = HET and Original Applicant = APPLIED MEDICAL RESOURCES CORP.
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