FDAFDA · Food and drugs·Recall number Z-0964-2021
B7-2LA BALLOON CATHETER 13MM DIA 3.2, model no. B7-2LA - Product Usage: Used with endoscopes for injection of contrast medium or other medical fluid into the biliary or pancreatic tract.
Published February 17, 2021 · Recall initiated: January 4, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Aomori Olympus Co., Ltd.
- Distributor
- US Nationwide distribution.
- Lot
- 01K, 02K, 03K, 0XK, 98K, 99K, 9XK, 9YK, 9ZK
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Japan
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.