Class I recall Z-0133-2027: Ventec Life Systems, Inc.
Class I recall Z-0133-2027: Ventec Life Systems, Inc. (Washington): Ventec Life Systems, Inc. Dated 8 days ago, it is in the active follow-up window. Score 82/100. As of 2026-11-04, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Free preview: all 14 published fields of this record are shown below. Locked: 16 related WA FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-0133-2027 |
| Recalling firm | Ventec Life Systems, Inc. |
| Classification | Class I |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| Product | V*Home, Model Number: PRT-01444-000, Package PN:PRT-01445-000. used for ventilatory support. |
| Reason | Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy. |
| Quantity | 25,112 units |
| Distribution | Distribution US nationwide including Puerto Rico. |
| Recall initiated | 2026-09-17 |
| Reported | 2026-10-28 |
| Firm location | Bothell, WA, United States |
| Peer records CSV (17 WA records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-10-28
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Wed, 04 Nov 2026 21:30:53 GMT
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Peer benchmark and outreach value: Class I recall Z-0133-2027: Ventec Life Systems, Inc. and 17 Washington peers
- Washington FDAPulse records like this one: 17
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every Washington peer: $3,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
82 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Class I recall: the most serious category, typically requiring urgent corrective and preventive action (CAPA).
- Recall is still ongoing.
- Posted 8 days ago.
What is the FDAPulse record for Class I recall Z-0133-2027: Ventec Life Systems, Inc. in Washington?
Class I device recall Z-0133-2027 by Ventec Life Systems, Inc.: Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in syste
How does Class I recall Z-0133-2027: Ventec Life Systems, Inc. compare to other Washington FDAPulse records?
It is fresh: dated 8 days ago, inside the window where early outreach matters most. Its Predicate Speed & CAPA Advisory Opportunity Score of 82/100 puts it among the stronger signals in this feed.
Class I recall Z-0133-2027 vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Class I recall Z-0133-2027 | WA | 2026-10-28 |
| Class I recall Z-0127-2027 | WA | 2026-10-28 |
| Class I recall Z-0132-2027 | WA | 2026-10-28 |
| Class I recall Z-0131-2027 | WA | 2026-10-28 |
Compare Class I recall Z-0133-2027 vs Class I recall Z-0122-2027 →
Compare Class I recall Z-0133-2027 vs Class I recall Z-0123-2027 →
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