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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 Kits see related information
Date Initiated by Firm April 24, 2020
Create Date May 11, 2020
Recall Status1 Terminated 3 on May 26, 2022
Recall Number Z-1963-2020
Recall Event ID 85594
Product Classification Kit, surgical instrument, disposable - Product Code KDD
Product DeRoyal Sterile Custom Kits packaged as a Piggy Back with the BD PosiFlush SF Saline Flush Syringe, labeled as follows:
a. H* Vein Pack Pgybk, 89-6209.03

b. H* Vein Pack, 89-6209.04

c. PICC Line Tray Pgybk, 89-6150.12

d. Umbilical Arterial Cath, 89-9370.01

e. Port Pack Pgybk, 89-8748.03

f. Port Pack Pgybk, 89-8748.04

g. Central Line Pack Pgybk, 89-8448.02

h.CV Insertion Kit II Pgybk, 89-9417.03

I. CV Insertion Kit II Pgybk, 89-9417.04

j. Right Heart Introducer Pgybk, 89-8495.04

k. Vein Pack Pgybk, 89-10400.01
Code Information a. 89-6209.03: Lot number: 49935860 exp 4/1/2021  b. 89-6209.04: Lot numbers: 51458994 exp 2/1/2022, 51220521 exp 2/1/2022, 51382467 exp 2/1/2022, 51836975 exp 4/1/2022, 51006728 exp 10/1/2021   c. 89-6150.12: Lot numbers: 49896872 exp 11/1/2021, 50381438 exp 12/1/2021, 50129726 exp 12/1/2021, 51602562 exp 2/1/2022, 51347371 exp 2/1/2022, 51788951 exp 4/1/2022, 50784528 exp 8/1/2021, 51006787 exp 1/1/2022   d. 89-9370.01: Lot numbers: 50110742 exp 7/1/2020, 50601672 exp 7/1/2020, 51008408 exp 5/1/2021, 51284787 exp 8/1/2021   e. 89-8748.03: Lot Number 49989657 exp 12/1/2021    f. 89-8748.04: Lot numbers: 50275125 exp 12/1/2021, 50129064 exp 12/1/2021, 51791631 exp 12/1/2021, 51434765 exp 2/1/2022, 51925556 exp 4/1/2022, 50879543 exp 1/1/2022, 51030197 exp 1/1/2022   g. 89-8448.02: Lot numbers: 50477253 exp 10/1/2020, 50129072 exp 1/1/2021, 50570141 exp 2/1/2021   h.89-9417.03: Lot number: 50375468 exp 10/1/2020  i. 89-9417.04: Lot numbers: 51604074 exp 5/1/2021, 51733028 exp 5/1/2021, 52033357 exp 5/1/2021, 50630967 exp 2/1/2021, 50829255 exp 4/1/2021   j. 89-8495.04: Lot numbers: 50612902 exp 10/1/2020, 51791800 exp 2/1/2021, 50905238 exp 2/1/2021, 50919891 exp 2/1/2021, 51252849 exp 2/1/2021   k. 89-10400.01: Lot numbers: 51556261 exp 2/1/2021, 51881274 exp 2/1/2022, 51974930 exp 2/1/2022, 51473449 exp 10/1/2021, 51984388 exp 4/1/2022  
Recalling Firm/
Manufacturer		 DeRoyal Industries Inc
200 Debusk Ln
Powell TN 37849-4703
For Additional Information Contact Brian DeBusk
865-362-1284
Manufacturer Reason
for Recall		 DeRoyal manufactured procedure packs using BDPosiFlush syringes which were subsequently recalled due holes in the packaging.
FDA Determined
Cause 2		 Other
Action DeRoyal initiated the recall by email on 04/24/2020. The letter requested the consignee take the following actions: "1. Using the attached Affected Products Listing, identify affected surgical pack numbers in your inventory and place in quarantine to prevent further use. Please return the entire affected surgical packs that you have in inventory to us. You will be given replacement or credit for the returned product. 2. Complete the NOTICE OF RETURN FORM-CREDIT ONLY, indicating all affected products found in your inventory. Please return the completed form to DeRoyal via fax to 865-362-3716 or email to recalls@deroyal.com no later than May 15, 2020. 3. If you have questions regarding replacement or credit for the recall, please contact Jennifer Marsh at jmarsh@deroyal.com or by phone 865-362-4203 or email us at recalls@deroyal.com. 4. PLEASE COMPLETE AND RETURN THIS FORM EVEN IF YOU NO LONGER HAVE ANY INVENTORY. 5. If you have further distributed these products, it is required that your customers be notified of this recall. You may either do this directly and notify us that you have done so, or you may provide us with your customer listing and we will contact them.
Quantity in Commerce 352 trays with 7923 syringes
Distribution US distribution in the states of TN, MD, MN, ND, NY, FL, MA, RI
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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