Ref: 3598 Safescraper Twist recall: Sterility Concern
REF: 3598 SAFESCRAPER TWIST, CE 0123, STERILE EO. Used in oral surgery.
Why was Ref: 3598 Safescraper Twist recalled?
Sterility issues; single use devices labeled as sterile may not have been adequately sterilized
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?
Lot number: 26-33118 and 17-19818
- Product
- REF: 3598 SAFESCRAPER TWIST, CE 0123, STERILE EO. Used in oral surgery.
- Recalling firm
- Meta C.G.M. Spa
- Quantity
- 150 units
- Distribution
- Distribution in US states of Texas and Florida
- Recall date
- June 9, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)