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Class 2 Device Recall AdeptMed |
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Date Initiated by Firm |
August 17, 2004 |
Date Posted |
June 22, 2006 |
Recall Status1 |
Terminated 3 on December 28, 2006 |
Recall Number |
Z-1156-06 |
Recall Event ID |
35406 |
510(K)Number |
K802806 K870809
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Product Classification |
Retainer Fish - Product Code GZC
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Product |
Adept-Med brand Glassman Viscera Retainer FISH Sterile, Item Numbers: 3204, 3202, 3203, 3202, 3201, 3200, 3206; Product is manufactured and distributed by Adept-Med International, Inc., 665 Pleasant Valley Rd., Diamond Springs, CA 95619
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Code Information |
1104, 1204, 11203, 11103, 11503, 11403, 10503 |
Recalling Firm/ Manufacturer |
Adept-Med International Inc 694 Pleasant Valley Rd Ste 4 Diamond Springs CA 95619-9249
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For Additional Information Contact |
Christine Quigley 800-222-8445
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Manufacturer Reason for Recall |
Devices for which sterility may be compromised as evidenced by a loss of package integrity.
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FDA Determined Cause 2 |
Other |
Action |
On 8/13/04, the firm initiated the recall and its notification was via letters explaining the reason for the recall and requesting the product be returned. |
Quantity in Commerce |
7,600 units |
Distribution |
Nationwide-The product was released for distribution to 249 consignees in US. The firm identified 242 hospitals and 7 distributors. The recall was appropriately extended to the consumer/user level; i.e., the wholesalers/distributors, pharmacists, hospitals who received the recalled product.
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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 = GZC and Original Applicant = ADEPT-MED INTL., INC.
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