The Recall Desk
HighFDA (Devices)·Z-1963-2020·Announced 2020-05-20

DeRoyal Sterile Custom Kits Recalled Due to Packaging Holes

DeRoyal Industries is recalling sterile custom kits packaged with BD PosiFlush syringes because holes in the packaging may compromise sterility.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves compromised sterility in medical devices, which poses a risk of infection (harm) to patients, but the source text does not report any specific illnesses or injuries.

Plain-English summary

DeRoyal Industries Inc is recalling specific sterile custom kits that were packaged as a piggyback with BD PosiFlush SF Saline Flush Syringes. The recall is being conducted because the packaging for these kits has holes, which may compromise the sterile integrity of the medical devices.

The affected products include various procedure packs such as Vein Packs, PICC Line Trays, Umbilical Arterial Catheters, Port Packs, Central Line Packs, CV Insertion Kits, and Right Heart Introducers. The recall covers 352 trays containing 7,923 syringes. These products were distributed in the United States to the states of Tennessee, Maryland, Minnesota, North Dakota, New York, Florida, Massachusetts, and Rhode Island.

Healthcare facilities and consumers should stop using the affected lots immediately. The specific lot numbers and expiration dates for the recalled items are listed in the official FDA recall notice Z-1963-2020. Users should contact DeRoyal Industries Inc for further instructions on returning or disposing of the affected products.

The recalled product

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. P
Manufacturer
DeRoyal Industries Inc
Category
Medical Device — Sterile Procedure Packs
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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
  • 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

Distribution

Distributed in 8 states:

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