A.R.C. Laser Photolysis Probe/Handpiece
FDA device recall Z-0981-03 · posted 2003-07-03 · Terminated
Recall details
- Recalling firm
- A.R.C. Laser Corp
- Reason for recall
- Product may not have been properly sterilized.
- Action taken
- The 5 consignees were notified by phone on 06/06/2003, followed by fax and letter notification on 06/10/2003.
- Root cause
- Other
- Status
- Terminated
- Product code
- GEX
- Quantity affected
- 370 units
- Distribution
- IN, NY, PA, TX.
- Date initiated
- 2003-06-06
- Date posted
- 2003-07-03
- Date terminated
- 2003-07-23
- Location
- Salt Lake City, UT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LASER PHOTOLYSIS SYSTEM, PHARO OPHTHALMIC SURGERY SYSTEM (K993154) | A.R.C. Laser Corp. | 2000-06-29 |