FDA Device recall Z-2325-2012
100 ft roll of tubing inside a cardboard box
- FDA Device
- Class III
- terminated
- Published 2012-09-12
On 2012-09-12 the FDA classified a Class III recall of 100 ft roll of tubing inside a cardboard box by Steris, citing on 7/20/2012 the firm became aware that a lot of tubing was distributed by the supplier after it was rejected by Steris due to failing process indicators.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2325-2012 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2012-08-02 |
| Published | 2012-09-12 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Steris |
| Distribution | US |
Product
100 ft roll of tubing inside a cardboard box. Medical devices are sealed into the tubes prior to ethylene oxide sterilization. Tube maintains sterility of the enclosed medical devices until opened.
Reason
On 7/20/2012 the firm became aware that a lot of tubing was distributed by the supplier after it was rejected by Steris due to failing process indicators.
Identifiers
| code_info | Product code KCT; Lot number: 60263 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2325-2012%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.