Cardinal Health 200, LLC recalls Presource Convenience Kits: 1) KIT
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.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Presource Convenience Kits: 1) KIT, USGPIV , Catalog Number: PVMHIVMHD; 2) KIT, USGPIV , Catalog Number: PVMHIVM14; 3) KIT, USGPIV , Catalog Number: PVMHIVM15
Lot / code information
- UDI
- 10197106488959(each), 50197106488957(case)
- Lot #
- 20 ; 2) PVMHIVMHD
- UDI
- 10197106488959(each), 50197106488957(case)
- Lot #
- 5126398 ; 3) PVMHIVMHD
- UDI
- 10197106488959(each), 50197106488957(case)
- Lot #
- 5126398 ; 4) PVMHIVMHD
- UDI
- 10197106488959(each), 50197106488957(case)
- Lot #
- 5129488 ; 5) PVMHIVMHD
- UDI
- 10197106488959(each), 50197106488957(case)
- Lot #
- 5181074 ; 6) PVMHIVMHD
- UDI
- 10197106488959(each), 50197106488957(case)
- Lot #
- 5181074 ; 7) PVMHIVMHD
- UDI
- 10197106488959(each), 50197106488957(case)
- Lot #
- 5182660 ; 8) PVMHIVMHD
- UDI
- 10197106488959(each), 50197106488957(case)
- Lot #
- 5188103 ; 9) PVMHIVMHD
- UDI
- 10197106488959(each), 50197106488957(case)
- Lot #
- 5126398 ; 10) PVMHIVMHD
- UDI
- 10197106488959(each), 50197106488957(case)
- Lot #
- 5181074 ; 11) PVMHIVMHD
- UDI
- 10197106488959(each), 50197106488957(case)
- Lot #
- 5188103 ; 12) PVMHIVMHD
- UDI
- 10197106488959(each), 50197106488957(case)
- Lot #
- 5188102 ; 13) PVMHIVMHD
- UDI
- 10197106488959(each), 50197106488957(case)
- Lot #
- 5199118 ; 14) PVMHIVMHD
- UDI
- 10197106488959(each), 50197106488957(case)
- Lot #
- 5188103 ; 15) PVMHIVMHD
- UDI
- 10197106488959(each), 50197106488957(case)
- Lot #
- 5195818 ; 16) PVMHIVMHD
- UDI
- 10197106488959(each), 50197106488957(case)
- Lot #
- 5150160 ; 17) PVMHIVMHD
- UDI
- 10197106488959(each), 50197106488957(case)
- Lot #
- 5195818 ; 18) PVMHIVMHD
- UDI
- 10197106488959(each), 50197106488957(case)
- Lot #
- 5210853 ; 19) PVMHIVMHD
- UDI
- 10197106488959(each), 50197106488957(case)
- Lot #
- 5248375 ; 20) PVMHIVMHD
- UDI
- 10197106488959(each), 50197106488957(case)
- Lot #
- 5276968 ; 21) PVMHIVMHD
- UDI
- 10197106488959(each), 50197106488957(case)
- Lot #
- 5350797 ; 22) PVMHIVMHD
- UDI
- 10197106488959(each), 50197106488957(case)
- Lot #
- 5279226 ; 23) PVMHIVMHD
- UDI
- 10197106488959(each), 50197106488957(case)
- Lot #
- 5350797 ; 24) PVMHIVMHD
- UDI
- 10197106488959(each), 50197106488957(case)
- Lot #
- 5307185 ; 25) PVMHIVMHD
- UDI
- 10197106488959(each), 50197106488957(case)
- Lot #
- 5310701 ; 26) PVMHIVMHD
- UDI
- 10197106488959(each), 50197106488957(case)
- Lot #
- 6051588 ; 27) PVMHIVM14
- UDI
- 10198956165434(each), 50198956165432(case)
- Lot #
- 5126398 ; 28) PVMHIVM15
- UDI
- 10198956184459(each), 50198956184457(case)
- Lot #
- 5129058
Show 46 more code fieldsShow fewer
What the firm is doing
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: gmb-FieldCorrectiveAction@cardinalhealth.com 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.
DistributionShow detailsHide
US Nationwide distribution in the states of FL, KY, MO, NC, OH, TX.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-3255-2026
- FDA device classification · OWLOfficial FDA classification for this device type
- CFR regulation · 21 CFR 880.5200The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Cardinal Health 200, LLCSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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