—#142507

Product

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.

FDA product code: MJC — Catheter, Urological (Antimicrobial) And Accessories
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K910318
Affected lot / code info: CodeCatalog numbers: 0146SI16, 0146SI18, 0146SI20 and 0146SI22. All lot numbers produced with IFU (PK7634040) are affected.

Why it was recalled

Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect inflation volume.

Root cause (FDA determination)

Error in labeling

Action the firm took

C. R. Bard, Inc. sent a "NOTIFICATION OF MISLABELING" letter, dated 12/18/2015 to all affected consignees. The letter identifies the product, problem, and actions to be taken by the customers.

Recalling firm

Firm: C.R. Bard, Inc.
Address: 8195 Industrial Blvd NE, Covington, Georgia 30014-1497

Distribution

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

Timeline

Recall initiated: 2015-12-18
Terminated: 2016-06-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #142507. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.