Injector Forcemax Lower recall: Sterility Concern
INJECTOR FORCEMAX LOWER 25G 6MM, model no. NM-400U-0625 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of…
Why was Injector Forcemax Lower recalled?
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 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?
01K, 02K, 03K, 05K, 06K, 09K, 98K, 9XK, 9YK, 05V, 06V, 07V, 08V, 09V, 0XV
- Product
- INJECTOR FORCEMAX LOWER 25G 6MM, model no. NM-400U-0625 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of…
- Recalling firm
- Aomori Olympus Co., Ltd.
- Quantity
- 7,400,000 (globally); 260,395 (US)
- Distribution
- US Nationwide distribution.
- Recall date
- February 17, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)