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U.S. Department of Health and Human Services

Class 2 Device Recall DeRoyal Specimen Retrieval Bag

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 Class 2 Device Recall DeRoyal Specimen Retrieval Bagsee related information
Date Initiated by FirmApril 17, 2015
Date PostedMay 21, 2015
Recall Status1 Terminated 3 on December 29, 2015
Recall NumberZ-1642-2015
Recall Event ID 71193
510(K)NumberK132375 
Product Classification Laparoscope, general & plastic surgery - Product Code GCJ
ProductDeRoyal(R) Medium Specimen Retrieval Bag, REF 5500-000-003, Rx Only Product Usage: The device is a single-use specimen retrieval bag indicated for use in laparoscopic procedures to capture and remove organs or tissue from the body cavity.
Code Information 1211QDA403, 1301QDA402, 1301QDA410, 1303QDA401, 211QDA403, 32046564, 32119911, 32338381, 32562251, 32783812, 32886441, 32891051, 32899882, 32942609, 33114274, 34939294, 35229930, 35579999, 35738515
Recalling Firm/
Manufacturer		 DeRoyal Industries Inc
200 Debusk Ln
Powell TN 37849-4703
For Additional Information ContactMr. Tracy Edmundson
865-362-2334
Manufacturer Reason
for Recall		The firm received reports of specimen retrieval bags tearing, ripping, and coming apart during use.
FDA Determined
Cause 2		Device Design
ActionDeRoyal sent an Urgent: Voluntary Recall letter dated April 17, 2015 to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to 1. Check your inventory for the product and specific lot number from the attached Recall Response Form. 2. If you have affected inventory, please destroy it and dispose of it according to your facilitys procedures. 3. Record all information on the included Recall Response and Notice of Destruction forms. 4. If you purchase through a distributor, please indicate their name/location on the Notice of Destruction Form so that we may issue credit appropriately. 5. Return both forms to recalls@deroyal.com or 865-362-3716 (fax) even if you no longer have affected inventory. 6. Once we have received your Recall Response and Notice of Destruction forms, you will receive credit for destroyed product as indicated on the form. 7. If you are a distributor of these products, please forward this recall notice on to your end-users, or provide us with your customer listing and we will gladly contact them for you. For questions regarding this recall, please contact your DeRoyal Sales Representative or DeRoyal Customer Service at 1-800-251-9864.
Quantity in Commerce5359 units
DistributionUS Nationwide Distribution
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 = GCJ
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