Recall record at a glance
| Official record | Z-3102-2026 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Cardinal Health 200, LLC |
| Report date | Sep 9, 2026 |
| Recall initiation date | Jul 29, 2026 |
| Quantity | 956 units |
| Location | Waukegan, IL, United States |
Official product description
Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, ROBOTIC HYST , Catalog Number: PB41RHRM3; 2) KIT, ROBOTIC HYST , Catalog Number: PB41RHRM4; 3) KIT, C SECTION , Catalog Number: PLVMCS22G; 4) KIT, C SECTION MARTIN , Catalog Number: PL22CSMMI; 5) KIT, C SECTION MARTIN , Catalog Number: PL22CSMMI; 6) KIT, C SECTION OREGON HEALTH , Catalog Number: PL57CS60N; 7) C SECTION PACK , Catalog Number: SMAHBCSECB; 8) C SECTION PACK , Catalog Number: SMAHBCSEC3
Why the product was recalled
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.
Distribution information
US Nationwide distribution.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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