Recall Z-1291-2025 ยท GAZ Tubing, Noninvasive
DeRoyal Industries Inc
DeRoyal REF 71-C5100NS Tubing, Suction, Connector; DeRoyal REF 71-C6100NS Tubing, Suction, Connector; DeRoyal REF 71-C7100NS Tubing, Suction, Connector Indicated use - Fluid Movement
| Date | Mar 5, 2025 (initiated Jan 31, 2025) |
| Status | Open, Classified |
| Reason | Due to the inner diameter of the suction tubing connector being smaller than the suction canister lid port connection. This size difference, combined with the durometer of the plastic material, makes the assembly to a suction canister lid port difficult. This could result in inadequate suction and cause a delay in patient care. |
| Root cause | Under Investigation by firm |
| Action | On 01/31/2025, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Letter via email to customers informing them that bulk roll, non-sterile suction connector tubing products and lots which could possibly be defective. The inner diameter of the suction tubing connector, is smaller than the suction canister lid port connection. This size difference, combined with the durometer of the plastic material, makes the assembly to a suction canister lid port difficult. This could result in inadequate suction and cause a delay in patient care. Customers are instructed to: 1) Identify affected product numbe |
| Quantity | 714 cases |
| Distribution | U.S.: IL, MN, NC, PA, and VA O.U.S.: N/A |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.