DeRoyal Industries Inc recalls DeRoyal Sterile Custom Kits packaged as a Piggy Back with the BD PosiFlush SF Saline Flush Syringe, labeled as follows:…

Recall date

April 24, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1963-2020

FDA classification

Class II

Brand / firm

DeRoyal Industries Inc

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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