Recall Z-1157-2023 ยท LRS I.V. Start Kit
Cardinal Health 200, LLC
Cardinal Health Presource Packs IV START KIT- Intended for IV access device CATALOG #: 01-5798B
| Date | Feb 22, 2023 (initiated Nov 18, 2022) |
| Status | Open, Classified |
| Reason | Presource Kits contains the ICU MicroClave Clear Connector due to a manufacturing defect there is a gap between the connectors top and bottom housings which may lead to fluid leaks and loss of fluid path integrity |
| Root cause | Nonconforming Material/Component |
| Action | Cardinal Health issued Urgent: Product Correction letter and Acknowledgement Form was sent overnight on November 18, 2022 to the direct consignees. Letter states reason for recall, health risk and action to take: If you locate affected product within your facility, please do the following: 1. QUARANTINE affected kits. 2. ALERT your clinicians of this action. 3. AFFIX a WARNING LABEL to the front of each Presource kit so that it is clearly visible to clinicians, instructing them to remove and discard the recalled component(s). 4. RETURN a copy of the enclosed Acknowledgment Form confirming you |
| Quantity | 4560 EA |
| Distribution | US Nationwide distribution in the states of GA, PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.