Reported May 20, 2020 · Terminated
DeRoyal Sterile Custom Kits packaged as a Piggy Back with the BD PosiFlush SF Saline Flush Syringe, labeled as follows:…
DeRoyal Industries Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: DeRoyal Industries Inc · 200 Debusk Ln · Powell, TN · 37849-4703
Is this the product you have?
DeRoyal Sterile Custom Kits packaged as a Piggy Back with the BD PosiFlush SF Saline Flush Syringe, labeled as follows
10 of 10 products
| # | Product as published |
|---|---|
| 1 | H* Vein Pack Pgybk, 89-6209.03 |
| 2 | H* Vein Pack, 89-6209.04 |
| 3 | PICC Line Tray Pgybk, 89-6150.12 |
| 4 | Umbilical Arterial Cath, 89-9370.01 |
| 5 | Port Pack Pgybk, 89-8748.03 |
| 6 | Port Pack Pgybk, 89-8748.04 |
| 7 | Central Line Pack Pgybk, 89-8448.02 h.CV Insertion Kit II Pgybk, 89-9417.03 |
| 8 | CV Insertion Kit II Pgybk, 89-9417.04 |
| 9 | Right Heart Introducer Pgybk, 89-8495.04 |
| 10 | Vein Pack Pgybk, 89-10400.01 |
- Lot codes and dates
11 of 11 products
Products covered by this recall # Product as published 1 Lot number: 49935860 exp 4/1/2021 b. 89-6209.04 2 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 3 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 4 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 5 Lot Number 49989657 exp 12/1/2021 f. 89-8748.04 6 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 7 Lot numbers: 50477253 exp 10/1/2020, 50129072 exp 1/1/2021, 50570141 exp 2/1/2021 h.89-9417.03 8 Lot number: 50375468 exp 10/1/2020 i. 89-9417.04 9 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 10 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 11 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 - Amount recalled
- 352 trays with 7923 syringes
Where it was sold
Why it was recalled
DeRoyal manufactured procedure packs using BDPosiFlush syringes which were subsequently recalled due holes in the packaging.
This product could cause temporary or reversible health problems — stop using it.
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