Class II recall Z-3328-2026: SPECTRUM MEDICAL SRL
Class II recall Z-3328-2026: SPECTRUM MEDICAL SRL: SPECTRUM MEDICAL SRL. Dated 29 days ago, it is in the active follow-up window. Score 62/100. 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: 499 related FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-3328-2026 |
| Recalling firm | SPECTRUM MEDICAL SRL |
| Classification | Class II |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| Product | Brand Name: Quantum PureFlow Product Name: Quantum PureFlow Standard Heat Exchanger High Flow 3/8 Model/Catalog Number: HX55W-S0 Software Version: N/A Product Description: The Quantum PureFlow Standard Heat Exchanger is intended to be used with a compatible Heater/Cooler system to heat/cool blood during routine cardiopulmonary bypass (CPB) procedures up to 6 hours in duration with a maximum flow rate of 8 l/min. Quantum PureFlow Standard Heat Exchanger is a single use device which allows heating/cooling the blood during extracorporeal circulation. The device is sold sterile in a blister |
| Reason | Due to blood-to-glycol leak in the heat exchanger. |
| Quantity | 3232 |
| Distribution | US Nationwide distribution in the states of AL, CA, FL, KS MA, MD, MI, MO, NC, NJ, NY, OH, OR, PA, SC, TN, TX, VA, WI. |
| Recall initiated | 2026-07-17 |
| Reported | 2026-10-07 |
| Firm location | Mirandola, Italy |
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CSV columns: Record · Specialty · Date · Review days · Recall class · official source URL
- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-10-07
- 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 09:16:12 GMT
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62 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Class II recall: usually triggers CAPA and quality-system remediation work.
- Recall is still ongoing.
- Posted 29 days ago.
What is the FDAPulse record for Class II recall Z-3328-2026: SPECTRUM MEDICAL SRL?
Class II device recall Z-3328-2026 by SPECTRUM MEDICAL SRL: Due to blood-to-glycol leak in the heat exchanger.
How does Class II recall Z-3328-2026: SPECTRUM MEDICAL SRL compare to other FDAPulse records?
It is 29 days old, still within a typical 45-day follow-up window.
Class II recall Z-3328-2026 vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Class II recall Z-3328-2026 | 2026-10-07 | |
| Class II recall Z-3155-2026 | MA | 2026-10-07 |
| Class II recall Z-0232-2027 | 2026-10-28 | |
| Class II recall Z-0243-2027 | 2026-10-28 |
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