Bard

The brochures were purchased from the vendor on 04/14/2015, Code S120667R0

General Hospital and Personal Use Devices

2

Yes

Distributed to domestic and foreign conference attendees.

Marketing brochures for the PowerPICC and PowerPICC SOLO catheters

Catalog numbers: 0165I108 and 065SI10; All lot numbers produced with IFU (PK7634040) are affected.

Gastroenterology-Urology Devices

2

No

Distributed US (nationwide) and the countries of Canada and Australia.

BARDEX I.C. Anti-Infective 2-Way 3cc Foley Catheter, Rx only. Intended for urinary bladder drainage in female patients requiring catheterization for management of incontinence, voiding dysfunction and surgical procedure.

Code(s): Catalog numbers: 01655SI12, 01655SI14, 01655SI16, 01655SI18, 01655SI20, 01655SI22, 01655SI24, 01655SI26, 01655SI28 and 01655SI30. All lot numbers produced with IFU (PK7634040) are affected.

Gastroenterology-Urology Devices

2

No

Distributed US (nationwide) and the countries of Canada and Australia.

BARDEX I.C. Anti-Infective 2-Way 5cc Foley Catheter. Intended for urinary bladder drainage in female patients requiring catheterization for management of incontinence, voiding dysfunction and surgical procedure.

CodeCatalog numbers: 0146SI16, 0146SI18, 0146SI20 and 0146SI22. All lot numbers produced with IFU (PK7634040) are affected.

Gastroenterology-Urology Devices

2

No

Distributed US (nationwide) and the countries of Canada and Australia.

BARDEX I.C. Anti-Infective 2-Way Red Latex Foley Catheter, 5cc (Council Model); Intended for urinary bladder drainage in female patients requiring catheterization for management of incontinence, voiding dysfunction and surgical procedure.