ConvaTec, Inc: Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile R
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- ConvaTec, Inc
- Product
- Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile R
- Reason / hazard
- Surgical dressing manufactured out of specification (greater thickness).
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- US Nationwide distribution in the states of MD, OH, IL, NC, AZ, NY, MN, TX, KS, TN, IN, DE, MI, FL, PA, CA, VA, MS, NM, GA, CO.
- Recall initiated
- 2026-06-08
- Code info
- Lot/Batch: 5G00809; Primary Pack UDI: (01) 00768455130764/ Secondary Pack UDI: (01) 00768455130634/ Tertiary Pack UDI: (01) 10768455130631
- Product quantity
- 4230 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Greensboro
- State
- NC
- Country
- United States
- Event id
- 99151
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