FDA Medical Device Recalls (openFDA)
DeRoyal Industries Inc: 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
- Recall number
- Z-1963-2020
- Recalling firm
- DeRoyal Industries Inc
- 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
- Status
- Terminated
- Initiated
- 2020-04-24
- Posted
- not on file
- Terminated
- 2022-05-26
- Reason
- DeRoyal manufactured procedure packs using BDPosiFlush syringes which were subsequently recalled due holes in the packaging.
- Root cause
- 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
- 352 trays with 7923 syringes
- Distribution
- US distribution in the states of TN, MD, MN, ND, NY, FL, MA, RI
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KDD
- Firm FEI
- 1043214
- Firm city
- Powell
- Firm state
- TN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28