Recall Z-3255-2026 ยท OWL Peripheral Catheter Insertion Kit
Cardinal Health 200, LLC
Presource Convenience Kits: 1) KIT, USGPIV , Catalog Number: PVMHIVMHD; 2) KIT, USGPIV , Catalog Number: PVMHIVM14; 3) KIT, USGPIV , Catalog Number: PVMHIVM15
| Date | Sep 22, 2026 (initiated Aug 10, 2026) |
| Status | Open, Classified |
| Reason | The kits contain applicators that may exhibit an open or incomplete seal on the packaging of the applicator. Use of a potentially contaminated applicator could result in no patient harm or may lead to localized skin or soft tissue infection. Less commonly, systemic infection or other infectious complications may occur. |
| Root cause | Nonconforming Material/Component |
| Action | An URGENT: PRODUCT CORRECTION notification letter dated 8/10/26 was sent to customers. 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 your receipt of this action and the completion of labeling product via fax to 614.652.9648. Additional labels will be sent to you |
| Quantity | 9480 kits |
| Distribution | US Nationwide distribution in the states of FL, KY, MO, NC, OH, TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.