FDA Device recall Z-3294-2026
Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays ABDOMINAL HYSTERECTOMY - 205989 Model No.…
- FDA Device
- Class II
- ongoing
- Published 2026-10-07
On 2026-10-07 the FDA classified a Class II recall of Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays ABDOMINAL HYSTERECTOMY - 205989 Model No.… by American Contract Systems, citing kits contain manufacturer-recalled perineal care (pericare) wipes within urinary catheter trays, which may be contaminated with a lubricant used during the manufacturing process.….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3294-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-08-10 |
| Published | 2026-10-07 |
| Last updated | 2026-10-13 05:30 UTC |
| Company | American Contract Systems |
| Distribution | US |
Product
Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays ABDOMINAL HYSTERECTOMY - 205989 Model No. MHAH55AM LAVH-LAP COLON Model No. SPLL54U VAG HYST PACK Model No. SPVH62P
Reason
Kits contain manufacturer-recalled perineal care (pericare) wipes within urinary catheter trays, which may be contaminated with a lubricant used during the manufacturing process. Use of a contaminated wipe may lead to localized skin effects such as irritation, erythema, or mild inflammation. Failure to perform pericare due to disposal of contaminated wipes may increase risk of localized infection or catheter-associated urinary tract infection (CAUTI).
Identifiers
| code_info | MHAH55AM UDI-DI 191072236487 Lots 42-8529911 42-8649211 42-8687711 42-8797811 42-8857011 42-8869711…MHAH55AM UDI-DI 191072236487 Lots 42-8529911 42-8649211 42-8687711 42-8797811 42-8857011 42-8869711 SPLL54U UDI-DI 191072239181 Lots 07-2516111 07-2528611 07-2545611 07-2547911 07-2561411 SPVH62P UDI-DI 191072238771 Lots 07-2544611 12-7436711 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-10-13 05:30 UTC. Current status: ongoing.
Other recalls by American Contract Systems
- Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays ROBOTIC PACK - 242561 Model No. MHRB88AO
FDA Device · Class II · 2026-10-07 · American Contract Systems - Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays CARDIAC HEART BUNDLE NS Model No. LMCH99P…
FDA Device · Class II · 2026-10-07 · American Contract Systems - American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AM
FDA Device · Class II · 2026-09-02 · American Contract Systems - American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AN
FDA Device · Class II · 2026-09-02 · American Contract Systems - American Contract System Convenience Kits, CV B PACK, Model/Catalog Number: TNCB10AP
FDA Device · Class II · 2026-09-02 · American Contract Systems
All American Contract Systems recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3294-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.