FDA Device recall Z-0186-2026
Medical convenience kits UDPG88W PICC G-TUBE PACK-230209
- FDA Device
- Class II
- ongoing
- Published 2025-10-22
On 2025-10-22 the FDA classified a Class II recall of Medical convenience kits UDPG88W PICC G-TUBE PACK-230209 by American Contract Systems, citing identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have no….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0186-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-09-04 |
| Published | 2025-10-22 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | American Contract Systems |
| Distribution | US |
Product
Medical convenience kits UDPG88W PICC G-TUBE PACK-230209
Reason
Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.
Identifiers
| code_info | UDPG88W UDI-DI 191072216359 lot 7935611 bag serial number N/A * If bag serial number is listed as "N/A", then whole lot is affected |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0186-2026%22
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