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U.S. Department of Health and Human Services

Class 2 Device Recall Various DeRoyal Surgical Kits

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  Class 2 Device Recall Various DeRoyal Surgical Kits see related information
Date Initiated by Firm September 10, 2015
Date Posted December 02, 2015
Recall Status1 Terminated 3 on June 22, 2018
Recall Number Z-0363-2016
Recall Event ID 72574
Product Classification General surgery tray (kit) - Product Code LRO
Product DeRoyal sterile custom surgical kits:
1) Emergency CABG Pack Pgybk, ref 89-7859.01
2) Emergency CABG Pack Pgybk, ref 89-7859.02
3) Open Heart Pack A&B Pgybk, ref 89-7750.02
4) Open Heart Pack A&B Pgybk, ref 89-7750.03
5) Intl-Cardiac Surgery Pack A&B Pgybk, ref 89-8514.02

GEO-MED sterile custom surgical kits:
1) Open Heart Pack Pgybk, ref 89-5792.10
2) Open Heart A&B Pgybk, ref 89-7626.02
3) Open Heart A&B Pgybk, ref 89-7626.03
4) Open Heat Pack A&B Pgybk, ref 89-8440.01
5) Open Heart Pack A&B Pgybk, ref 89-8440.02
Code Information Ref 89-7859.01: Lot numbers: 27369748, 27469087, 27964707, 28167081, 28207599, 28712544;  Ref 89-7859.02: Lot numbers: 35947501, 35550352, 38844461 Ref 89-7750.02: Lot numbers: 29929171, 30474952 Ref 89-7750.03: Lot numbers: 30984021, 31210924 Ref 89-8514.02: Lot numbers: 37392319, 37078506, 37109721, 36974376, 37057289, 36813530, 37086725, 37099609, 37253124, 37325378, 37401318, 37413132 Ref 89-5792.10: Lot numbers: 39821181, 39507167, 39072116, 39863866 Ref 89-7626.02: Lot numbers: 36068496, 359097163, 35543822, 35328356, 35428242, 35549693, 34939471, 33091009, 34952712 Ref 89-7626.03: Lot numbers: 39301960, 36660692, 37008882, 37210095, 37915491, 37217991, 40101164, 37519742, 38455852, 38756495, 39417057, 39714051, 39913835 Ref 89-8440.01: Lot numbers: 36674648, 36612412 Ref 89-8440.02: Lot number: 36987476
Recalling Firm/
Manufacturer		 DeRoyal Industries Inc
200 Debusk Ln
Powell TN 37849-4703
For Additional Information Contact Tracy Edmundson
865-362-2334
Manufacturer Reason
for Recall		 These custom sterile surgical kits contain the component, ECOLAB ORS Fluid Warming and Slush Drape, which was recalled due to the possibility that the sterile packaging may contain small channels in the seal of the pouch.
FDA Determined
Cause 2		 Other
Action DeRoyal issued their recall on 09/10/2015 to the end-user level by sending overnight letters to its direct accounts and hospitals. Distributors were asked to put the product in quarantine, place the provided labels on the products and complete. Hospitals were provided with labels to affix to the kits with the direction to discard the recalled component and notice of destruction forms to be completed and returned.
Quantity in Commerce 836 units
Distribution Distributed in MO, MA, NC, CT, Kuwait.
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.
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