Healthmark Industries Co., Inc.: Mesh Style Tip Protectors CSW-03-2.0 Open-end style CSW-04-4.0 Closed-end style
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Healthmark Industries Co., Inc.
- Product
- Mesh Style Tip Protectors CSW-03-2.0 Open-end style CSW-04-4.0 Closed-end style
- Reason / hazard
- Product does not have FDA clearance.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- US Nationwide distribution.
- Recall initiated
- 2026-03-12
- Code info
- No UDI. All lots affected.
- Product quantity
- 4,291,797
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Fraser
- State
- MI
- Country
- United States
- Event id
- 98627
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