Z-1583-2018 Class II Terminated
FDA device recall Z-1583-2018 was initiated by DeRoyal Industries Inc on Apr 23, 2018 and is designated Class II. Reason for recall: Non-sterile product was packaged inside a case that was labeled as sterile. The recall status is terminated (terminated Nov 9, 2018). Affected quantity: 1800 pencils.
Recall Details
- Product Type
- Devices
- Report Date
- May 9, 2018
- Initiation Date
- Apr 23, 2018
- Termination Date
- Nov 9, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1800 pencils
Product Description
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
Reason for Recall
Non-sterile product was packaged inside a case that was labeled as sterile.
Distribution Pattern
Honduras, Belgium, and The Netherlands
Code Information
Lot Number 44210051
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1583-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026