FDA Device recall Z-1963-2020

DeRoyal Sterile Custom Kits packaged as a Piggy Back with the BD PosiFlush SF Saline Flush Syringe, labeled as follows: a. H* Vein Pack Pgy…

FDA Device
Class II
terminated
Published 2020-05-20

On 2020-05-20 the FDA classified a Class II recall of DeRoyal Sterile Custom Kits packaged as a Piggy Back with the BD PosiFlush SF Saline Flush Syringe, labeled as follows: a. H* Vein Pack Pgy… by Deroyal Industries, citing deRoyal manufactured procedure packs using BDPosiFlush syringes which were subsequently recalled due holes in the packaging.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1963-2020
Classification	Class II
Status	terminated
Initiated	2020-04-24
Published	2020-05-20
Last updated	2026-09-13 11:55 UTC
Company	Deroyal Industries
Distribution	FL, MA, MD, MN, ND, NY, RI, TN

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

Reason

DeRoyal manufactured procedure packs using BDPosiFlush syringes which were subsequently recalled due holes in the packaging.

Identifiers

code_info	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… 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

code_info

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…

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1963-2020%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.