Recall Z-1357-2016— C.R. Bard, Inc.
Class II · Terminated
Class II FDA medical device recall by C.R. Bard, Inc., initiated 2015-12-18, terminated 2016-06-29. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect inflation volume..
- Recalling firm
- C.R. Bard, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-12-18
- Terminated
- 2016-06-29
- Firm location
- Covington, GA, United States
Product description
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.
Reason for recall
Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect inflation volume.
Data sourced from openFDA. This site is unofficial and independent of the FDA.