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Open, Classified

Presource Convenience Kits: 1) KIT, USGPIV , Catalog Number: PVMHIVMHD; 2) KIT, USGPIV , Catalog Number: PVMHIVM14; 3) KIT, USGPIV , Catalog Number: PVMHIVM15

FDA Recall Z-3255-2026 · Posted 2026-09-22

Recall StatusOpen, Classified
Product CodeOWL
Date Initiated2026-08-10
Product Quantity9480 kits

Reason for Recall

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.

Firm 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 your facility upon request. Please send an email to: [email protected] For component credit or replacement, please contact the following: " Hospitals Cardinal Customer Service at 866.551.0533 " Distributors Distributor Management at 800.635.6021 " Federal Government facilities Government Customer Service at 800.444.1166 If you are a Distributor and have further distributed affected kits please notify your customers of this recall. Should you have any questions, require additional labels or desire special assistance relating to this recall, please feel free to contact Cardinal Health Quality Systems at 800.292.9332.

Root Cause

Nonconforming Material/Component

Distribution Pattern

US Nationwide distribution in the states of FL, KY, MO, NC, OH, TX.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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