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DeRoyal Industries Inc recalls DeRoyal Sterile Custom Kits packaged as a Piggy Back with the BD PosiFlush SF Saline Flush Syringe, labeled as follows:
Recalled May 20, 2020 · FDA recall Z-1963-2020 · DeRoyal Industries
Hazard
DeRoyal manufactured procedure packs using BDPosiFlush syringes which were subsequently recalled due holes in the packaging. · FDA Class II
Units
352 trays with 7923 syringes
Sold at
US distribution in the states of TN, MD, MN, ND, NY, FL, MA, RI
Description
DeRoyal manufactured procedure packs using BDPosiFlush syringes which were subsequently recalled due holes in the packaging.
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
Manufacturer(s)
DeRoyal Industries Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →