# FDA recall Z-1963-2020

> **DeRoyal Industries Inc** · Class II · device recall initiated 2020-04-24.

## 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 for recall

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

## Distribution

US distribution in the states of TN, MD, MN, ND, NY, FL, MA, RI

## Key facts

- **Recall number:** Z-1963-2020
- **Recalling firm:** DeRoyal Industries Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-04-24
- **Report date:** 2020-05-20
- **Termination date:** 2022-05-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Powell, TN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1963-2020

## Citation

> AI Analytics. FDA recall Z-1963-2020. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/Z-1963-2020. Source: US FDA. Licensed CC0.

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