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U.S. Department of Health and Human Services

Class 2 Device Recall DeRoyal Sterile Custom kits

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 Class 2 Device Recall DeRoyal Sterile Custom kitssee related information
Date Initiated by FirmDecember 19, 2017
Create DateJanuary 12, 2018
Recall Status1 Terminated 3 on June 21, 2018
Recall NumberZ-0334-2018
Recall Event ID 78843
510(K)NumberK842648 
Product Classification General surgery tray - Product Code LRO
ProductDeRoyal Sterile Custom kits containing Covidien-Dover(TM) Irrigation Tray with Piston Syringe Containing Medline Aplicare Povidone Iodine Prep Pads, labeled as follows: (a) Shoulder Arthroscopy Pack 89-8686.01 (b) Shoulder Arthroscopy Pack 89-8686.02 (c) Knee Arthro Pack 89-8687.01 (d) Knee Arthro Pack 89-8687.02 Product Usage: general surgical
Code Information (a) Lot number: 38527131 (b) Lot numbers: 41450075, 41511034, 42143982, 44108769, 44274020, 44721168, 45599133, (c) Lot numbers: 38497294, 38564514, 40146320, 40990651 (d) Lot numbers: 41668816, 42839390, 44080575, 44871131, 45715430, 46232122
Recalling Firm/
Manufacturer		 DeRoyal Industries Inc
200 Debusk Ln
Powell TN 37849-4703
For Additional Information Contact
865-938-7828
Manufacturer Reason
for Recall		DeRoyal manufactured custom sterile surgical kits containing the Covidien-Dover(TM) Irrigation Tray with Piston Syringe that contains the Medline Aplicare Povidone Iodine Prep Pads. The Prep Pads were subsequently recalled because Medline Aplicare determined the product would not support the 36 month expiration date listed on the label.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionThe firm, DeRoyal, sent an "URGENT! RECALL NOTICE" letter dated 12/19/2017 to its Consignees overnight. The letter describe the product, problem and actions to be taken. The Consignees were instructed to identify affected product; place in quarantine to prevent further use, and complete and return the Affected Products Listing form to DeRoyal via fax to 865-362-3716 or email to recalls@deroyal.com no later than 1/15/2018, even if you no longer have any inventory. If you have questions or need assistance with the recall, please email jmarsh@deroyal.com or call by phone 865-362-4203 or email us at recalls@deroyal.com.
Quantity in Commerce226 kits
DistributionDistributed to states of: CA and MO.
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 = LRO
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