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STERILMED, INC. · Model BIOF5QF005CT · UDI-DI 10888551006828
NLH
Prescription
1
510(k) clearances
451
Adverse events (1 deaths)
49
Recalls
11
Facilities
Description
EP DIAGNOSTIC CATHETER WITH AUTO ID QUADRIPOLAR FIXED F CUFVE
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-08-18 | Stryker Sustainability Solutions | Diagnostic electrophysiology (EP) catheter may have a breached sterile barrier on the straight seal side of the primary pouch, which if used could lead to particulate embolization, |
| 2026-05-15 | Medline Industries, LP | Expansion of RES 98277. Specific lots of reprocessed catheters may contain small particles of residual material. If devices with residual particulates on patient-contacting surface |
| 2026-04-10 | Stryker Sustainability Solutions | Incomplete seals on sterile product |
| 2026-04-10 | Stryker Sustainability Solutions | Incomplete seals on sterile product |
| 2026-04-10 | Stryker Sustainability Solutions | Incomplete seals on sterile product |
| 2026-04-10 | Stryker Sustainability Solutions | Incomplete seals on sterile product |
| 2026-04-10 | Stryker Sustainability Solutions | Incomplete seals on sterile product |
| 2026-04-10 | Stryker Sustainability Solutions | Incomplete seals on sterile product |
| 2026-04-10 | Stryker Sustainability Solutions | Incomplete seals on sterile product |
| 2026-04-10 | Stryker Sustainability Solutions | Incomplete seals on sterile product |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.