Recall Z-1963-2020 ยท KDD Kit, Surgical Instrument, Disposable
DeRoyal Industries Inc
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 Pgy
| Date | Apr 24, 2020 |
| Status | Terminated |
| Reason | DeRoyal manufactured procedure packs using BDPosiFlush syringes which were subsequently recalled due holes in the packaging. |
| Root cause | Other |
| Action | 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 |
| Quantity | 352 trays with 7923 syringes |
| Distribution | US distribution in the states of TN, MD, MN, ND, NY, FL, MA, RI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.