American Catheter / Cholangiogram Catheter 9100 Series recall
American Catheter / Cholangiogram Catheter 9100 Series.
Why was American Catheter / Cholangiogram Catheter 9100 Series recalled?
Catheters were not sealed before sterilization. and was not detected through subsequent acceptance activities, product release and distribution.
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?
Product Number is 9100, Lot # 14101601.
- Product
- American Catheter / Cholangiogram Catheter 9100 Series.
- Recalling firm
- American Catheter Corp
- Quantity
- 890 devices.
- Distribution
- Distributed in the states of AL, AK, CA, CO, FL, GA, HI, IL, KS, LA, MI, MO, MT, NJ, OH, OK, SC, TN, TX, WA, and WI.
- Recall date
- July 29, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)