DeRoyal(R) SURGI MATE(R) Electrosurgical Pencil recall: Sterility Concern
DeRoyal(R) SURGI MATE(R) Electrosurgical Pencil, Button Switch, with 15 ft (4.6 m) Cord and Holster, REF 88-001502 Product Usage: general surgical
Why was DeRoyal(R) SURGI MATE(R) Electrosurgical Pencil recalled?
Non-sterile product was packaged inside a case that was labeled as sterile.
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 44210051
- Product
- DeRoyal(R) SURGI MATE(R) Electrosurgical Pencil, Button Switch, with 15 ft (4.6 m) Cord and Holster, REF 88-001502 Product Usage: general surgical
- Recalling firm
- DeRoyal Industries Inc
- Quantity
- 1800 pencils
- Distribution
- Honduras, Belgium, and The Netherlands
- Recall date
- May 9, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)