Class II recall Z-0147-2027: INTEGRATED MEDCRAFT LLC
Class II recall Z-0147-2027: INTEGRATED MEDCRAFT LLC (Connecticut): INTEGRATED MEDCRAFT LLC. Dated 14 days ago, it is in the active follow-up 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: 1 related CT FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-0147-2027 |
| Recalling firm | INTEGRATED MEDCRAFT LLC |
| Classification | Class II |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| Product | FORWARD Gunshot Wound Kit; Model: AFT-GSW; |
| Reason | Subrecall of a kitted device from SafeGuard Medical due to internal testing identified an issue affecting the device's sterile pad, potentially causing the sterile pad to degrade over time. The degradation may cause remnants of the nonwoven pad material to dislodge on the wound or in close proximity to the wound. |
| Quantity | 1033 |
| Distribution | US Nationwide distribution in the states of GA, VA. |
| Recall initiated | 2026-09-25 |
| Reported | 2026-10-21 |
| Firm location | East Hampton, CT, United States |
| Peer records CSV (2 CT records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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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: 2026-10-21
- 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-0147-2027: INTEGRATED MEDCRAFT LLC and 2 Connecticut peers
- Connecticut FDAPulse records like this one: 2
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every Connecticut peer: $400 (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 14 days ago.
What is the FDAPulse record for Class II recall Z-0147-2027: INTEGRATED MEDCRAFT LLC in Connecticut?
Class II device recall Z-0147-2027 by INTEGRATED MEDCRAFT LLC: Subrecall of a kitted device from SafeGuard Medical due to internal testing identified an issue affecting the device's s
How does Class II recall Z-0147-2027: INTEGRATED MEDCRAFT LLC compare to other Connecticut FDAPulse records?
It is fresh: dated 14 days ago, inside the window where early outreach matters most.
Class II recall Z-0147-2027 vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Class II recall Z-0147-2027 | CT | 2026-10-21 |
| 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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