Sd-400u-15 Snaremaster Plus Hot/cold 15m recall: Sterility Concern
SD-400U-15 SNAREMASTER PLUS Hot/Cold 15m, model no. SD-400U-15 - Product Usage: Used with endoscopes for the removal and/or cauterization of…
Why was Sd-400u-15 Snaremaster Plus Hot/cold 15m 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?
97V, 98V, 03V, 04V, 06V
- Product
- SD-400U-15 SNAREMASTER PLUS Hot/Cold 15m, model no. SD-400U-15 - Product Usage: Used with endoscopes for the removal and/or cauterization 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)