Arrow/Teleflex Medical Berman Angiographic Balloon recall: Labeling Error
Arrow/Teleflex Medical Berman Angiographic Balloon Catheter and Reverse Berman Angiographic Balloon Catheter. The Arrow Berman(TM) Angiographic…
Why was Arrow/Teleflex Medical Berman Angiographic Balloon recalled?
The product specifications sheet, part of the Instructions for Use (IFU), for the specified product numbers, reference Renografin-76 contrast medium (viscosity of 8.4 centipoise), which is no longer available. Firm is in the process of updating the labeling for these products. In the meantime, when choosing an alternative contrast medium, health care providers are instructed to select a contrast
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Part Numbers --AI-07035, AI-07131, AI-07135, AI-07037, AI-07132, AI-07136, AI-07130, AI-07133, AI-07137, AI-07130-J, AI-07134, AND AI-07138.
- Product
- Arrow/Teleflex Medical Berman Angiographic Balloon Catheter and Reverse Berman Angiographic Balloon Catheter. The Arrow Berman(TM) Angiographic…
- Recalling firm
- Arrow International Inc
- Quantity
- 99627ea
- Distribution
- Worldwide Distribution - USA including Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI and WV. and the countries of Australia, Dominican Republic, Uruguay, Ecuador, Chile, Taiwan, Pakistan, Colombia, Argentina, Korea Republic, New Zealand, Guatemala, Thailand, Peru, Bahamas, Philippines, Trinidad and Tobago, Japan, Ireland, India, Singapore, China, Canada and Mexico.
- Recall date
- April 10, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)