Class I — Sterilmed Inc
| Recalling firm | STERILMED, INC. |
|---|---|
| Registered facility | STERILMED, INC. (the firm's only registered facility) |
| Classification | Class I |
| Status | Terminated |
| Reason | Inadequate seal due to lack of adhesive glue |
| Product | St. Jude Medical. Agilis NxT Steerable Introducer: B1-Directional, Medium Curl 22.4 mm, 71 cm, 6.5 F ID; Dilator: 94 cm, 8.5 F; Super Stiff, Guidewire: 180 cm, 0.032". Reprocessed device for single use only, sterile. Product Usage: The reprocessed steerable introducer sheaths are indicated when introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum. |
| Quantity | 112 devices |
| Distribution | US Nationwide distribution in the states of AR, CO, FL, MI, OH, TX, and WA. |
| Initiated | 2017-06-02 |
| Classified | 2017-12-28 |
| Terminated | 2019-07-29 |
| Recall number | Z-0213-2018 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — Sterilmed Inc (Z-0213-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/77470/
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