ConvaTec, Inc: Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile R

Hazard

Surgical dressing manufactured out of specification (greater thickness).

Details from the source

Reason for recall: Surgical dressing manufactured out of specification (greater thickness). Distribution: 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. Quantity: 4230 units Lot/code info: Lot/Batch: 5G00809; Primary Pack UDI: (01) 00768455130764/ Secondary Pack UDI: (01) 00768455130634/ Tertiary Pack UDI: (01) 10768455130631

UPC codes

00768455130764, 00768455130634, 10768455130631

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.