Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

DeRoyal Sterile Custom Kits packaged as a Piggy Back with Recalled by DeRoyal Industries Inc Due to DeRoyal manufactured procedure packs using BDPosiFlush syringes which...

Date: April 24, 2020
Company: DeRoyal Industries Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact DeRoyal Industries Inc directly.

Affected Products

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

Quantity: 352 trays with 7923 syringes

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed to 8 states: FL, MD, MA, MN, NY, ND, RI, TN

Affected (8 states)Not affected

About DeRoyal Industries Inc

DeRoyal Industries Inc has 225 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report