FDAFDA · Food and drugs·Recall number Z-1010-2021
INJECTOR FORCEMAX UP 2.8MMCH 21G 6MM, model no. NM-400L-0621 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive 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, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Japan
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