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U.S. Department of Health and Human Services

Class 2 Device Recall AdeptMed

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 Class 2 Device Recall AdeptMedsee related information
Date Initiated by FirmAugust 17, 2004
Date PostedJune 22, 2006
Recall Status1 Terminated 3 on December 28, 2006
Recall NumberZ-1156-06
Recall Event ID 35406
510(K)NumberK802806 K870809 
Product Classification Retainer Fish - Product Code GZC
ProductAdept-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
Code Information 1104, 1204, 11203, 11103, 11503, 11403, 10503 
FEI Number 3000718212
Recalling Firm/
Manufacturer		 Adept-Med International Inc
694 Pleasant Valley Rd Ste 4
Diamond Springs CA 95619-9249
For Additional Information ContactChristine Quigley
800-222-8445
Manufacturer Reason
for Recall		Devices for which sterility may be compromised as evidenced by a loss of package integrity.
FDA Determined
Cause 2		Other
ActionOn 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 Commerce7,600 units
DistributionNationwide-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.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = GZC
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