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U.S. Department of Health and Human Services

Class 2 Device Recall GEOMED CABG PACK PGYBK A & B

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  Class 2 Device Recall GEOMED CABG PACK PGYBK A & B see related information
Date Initiated by Firm January 22, 2018
Create Date February 16, 2018
Recall Status1 Terminated 3 on August 19, 2020
Recall Number Z-0637-2018
Recall Event ID 79052
510(K)Number K842648  
Product Classification General surgery tray - Product Code LRO
Product Custom sterile surgical packs labeled as follows:
GEO-MED CABG PACK PGYBK A & B, REF 89-5985.07, STERILE EO

Use: Shoulder Arthroscopy
Code Information Lot numbers: 43097391, 43685581, 44750305, 45377442, 45464669, 45698684, 46203903
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 Terumo Over Pressure Safety Valve, which were subsequently recalled by Terumo CVS due to reports of 'No Flow' through the OPS valve.
FDA Determined
Cause 2		 Process change control
Action The firm, DeRoyal, sent an "URGENT! RECALL NOTICE" letter dated 01/22/18 to its Consignees on 1/22/18 by overnight mail. The firm sent a follow-up "URGENT! RECALL NOTICE" letter dated 1/29/18. The letters described the product, problem and actions to be taken. The Consignees were instructed to identify affected products; place in quarantine; complete and return the Notice of Return Form, even if they no longer held any affected product, to DeRoyal via fax to 865-362-3716 or email to recalls@deroyal.com no later than 3/1/18, and return any product they held in stock. If you have further distributed these products, notify your customers of this recall. If you have questions or need assistance with the recall, please contact Regulatory Recall Coordinator and Quality Projects Manager at jmarsh@deroyal.com or by phone 865-362-4203 or email us at recalls@deroyal.com.
Quantity in Commerce 181 units
Distribution US Distribution to: NY
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = LRO and Original Applicant = DEROYAL INDUSTRIES, INC.
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