Recall Z-1100-2023 ยท FPA Set, Administration, Intravascular
Quest Medical, Inc.
Precision Delivery Set with Filter, REF: PD06F; and Precision Delivery Set with Trifurcated Luer, REF: PDT05CV2
| Date | Feb 7, 2023 (initiated Dec 23, 2022) |
| Status | Open, Classified |
| Reason | Delivery Sets may have tubing that could become detached that could result in patient infection. |
| Root cause | Process control |
| Action | On 12/23/22, the recall notice was distributed. The customer was asked to return affected devices and to call 1-800-627-0226, extension 311, if they had any questions. |
| Quantity | 13,900 |
| Distribution | US Nationwide distribution in the state of MA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K202672 | Precision Delivery Infusion Set Quest Medical, Inc., Jan 21, 2021 |