Class II recall Z-0193-2027: B Braun Medical Inc
Class II recall Z-0193-2027: B Braun Medical Inc (Pennsylvania): B Braun Medical Inc. Dated 7 days ago, it is inside the fresh trigger window. Score 68/100. 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: 18 related PA FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-0193-2027 |
| Recalling firm | B Braun Medical Inc |
| Classification | Class II |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| Product | B Braun SAFSITE Injection Site, RV1000NC SAFSITE VALVE W/O EXTRA CAP. Catalog Number: 415068. |
| Reason | Potential for leakage and backflow at the Safsite valve. |
| Quantity | 461,300 units |
| Distribution | Worldwide - US Nationwide distribution in the states of CA, FL, IL, IN, MN, NJ, NY, OH, PA, TX, WA and the countries of Australia, Germany Malaysia, New Zealand. |
| Recall initiated | 2026-09-14 |
| Reported | 2026-10-28 |
| Firm location | Bethlehem, PA, United States |
| Peer records CSV (19 PA 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 09:16:12 GMT
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Peer benchmark and outreach value: Class II recall Z-0193-2027: B Braun Medical Inc and 19 Pennsylvania peers
- Pennsylvania FDAPulse records like this one: 19
- Timing: High: dated in the last 7 days
- Estimated pipeline if you contact every Pennsylvania peer: $3,800 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
68 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Class II recall: usually triggers CAPA and quality-system remediation work.
- Recall is still ongoing.
- Posted 7 days ago.
What is the FDAPulse record for Class II recall Z-0193-2027: B Braun Medical Inc in Pennsylvania?
Class II device recall Z-0193-2027 by B Braun Medical Inc: Potential for leakage and backflow at the Safsite valve.
How does Class II recall Z-0193-2027: B Braun Medical Inc compare to other Pennsylvania FDAPulse records?
It is fresh: dated 7 days ago, inside the window where early outreach matters most.
Class II recall Z-0193-2027 vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Class II recall Z-0193-2027 | PA | 2026-10-28 |
| 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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