Reported Jul 29, 2015 · Terminated
American Catheter / Cholangiogram Catheter 9100 Series.
American Catheter Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: American Catheter Corp · 13047 S Highway 475 · Ocala, FL · 34480-8503
Is this the product you have?
- American Catheter / Cholangiogram Catheter 9100 Series.
- Lot codes and dates
Product Number is 9100Lot # 14101601
- Amount recalled
- 890 devices.
Where it was sold
Why it was recalled
Catheters were not sealed before sterilization. and was not detected through subsequent acceptance activities, product release and distribution.
This product could cause temporary or reversible health problems — stop using it.
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