Recall Z-0094-2024 ยท FRN Pump, Infusion
EITAN MEDICAL LTD
Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural (REF 15032-000-0027) and SapphirePlus (REF 15038-000-0001)
| Date | Oct 20, 2023 (initiated Sep 11, 2023) |
| Status | Open, Classified |
| Reason | Infusion Pumps with affected software revision may fail to detect air in line, which may lead to air embolism. |
| Root cause | Software Design Change |
| Action | On 9/11/23, recall notices were emailed to customers informing them of the following: The Affected Pumps may fail to identify air in line when the following conditions are met: 1. The pump is operating on battery power (not connected to a power supply) 2. Treatments are water-like solutions (TPN and other opaque solutions are not affected) Until the Affected Pumps in your facility have been updated with new software, users are advised to only operate the effected devices as follows: i. Connect to continuous AC power during treatment (i.e., connect to a power supply) and/or; ii. Use with |
| Quantity | 1383 |
| Distribution | US nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K192860 | Sapphire Infusion Pump, Sapphire administration sets Q Core Medical , Ltd., Nov 19, 2020 |