Device product
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.
Z-1358-2016
Product summary
- Firm
- C.R. Bard, Inc.
- Event
- Event 72922
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,428,000 units (total)
- Official record key
device-enforcement:Z-1358-2016
Official wording
Reason: Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect inflation volume.
Code information: Code(s): Catalog numbers: 01655SI12, 01655SI14, 01655SI16, 01655SI18, 01655SI20, 01655SI22, 01655SI24, 01655SI26, 01655SI28 and 01655SI30. All lot numbers produced with IFU (PK7634040) are affected.
Distribution pattern: Distributed US (nationwide) and the countries of Canada and Australia.
Derived failure modes
-
Labeling or packaging
Labeling error