FDA Medical Device Recalls (openFDA)
Cardinal Health 200, LLC: Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, LUNG TX CIRCULATOR , Catalog Number: OVC3507231
- Recall number
- Z-3096-2026
- Recalling firm
- Cardinal Health 200, LLC
- Product
- Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, LUNG TX CIRCULATOR , Catalog Number: OVC3507231
- Status
- Open, Classified
- Initiated
- 2026-07-29
- Posted
- 2026-09-03
- Terminated
- not on file
- Reason
- The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is used on a patient, localized skin effects may occur. These may include irritation, erythema, or mild inflammation.
- Root cause
- Process change control
- Action
- An URGENT: PRODUCT CORRECTION notification letter dated 7/29/26 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. We sincerely apologize for any inconvenience this notice may have caused you and your staff. 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.
- Quantity
- 19 units
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- 1) OVC3507231, UDI-DI: 10198956232457(each), 50198956232455(case), Lot Number: NGKU0957
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LRP
- Firm FEI
- 3001236905
- Firm city
- Waukegan
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28