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

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

DeRoyal initiated the recall by email on 04/24/2020. The letter requested the consignee take the following actions: "1. Using the attached Affected Products Listing, identify affected surgical pack numbers in your inventory and place in quarantine to prevent further use. Please return the entire affected surgical packs that you have in inventory to us. You will be given replacement or credit for the returned product. 2. Complete the NOTICE OF RETURN FORM-CREDIT ONLY, indicating all affected products found in your inventory. Please return the completed form to DeRoyal via fax to 865-362-3716 or email to [email protected] no later than May 15, 2020. 3. If you have questions regarding replacement or credit for the recall, please contact Jennifer Marsh at [email protected] or by phone 865-362-4203 or email us at [email protected]. 4. PLEASE COMPLETE AND RETURN THIS FORM EVEN IF YOU NO LONGER HAVE ANY INVENTORY. 5. If you have further distributed these products, it is required that your customers be notified of this recall. You may either do this directly and notify us that you have done so, or you may provide us with your customer listing and we will contact them.