Recall Z-3099-2026 ยท OFX General Purpose Dental Tray
Cardinal Health 200, LLC
Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT,MAXILLOFACIAL PRESBYTERIAN, Catalog Number: PWV2MF01D
| Date | Sep 3, 2026 (initiated Jul 29, 2026) |
| Status | Open, Classified |
| 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 you |
| Quantity | 60 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.