Endo Ocular Directional Laser Probe, Lumenis Inc. Salt Lake City, UT STERILE EO
FDA device recall Z-2652-2010 · posted 2010-09-30 · Terminated
Recall details
- Recalling firm
- Lumenis, Inc.
- Reason for recall
- Firm did not have proper 510(K) clearance.
- Action taken
- Lumenis sent letters to all customers on 7/27/10 instructing them to review their inventory, isolate affected product, complete a recall verification form and return all affected product to them.
- Root cause
- Component change control
- Status
- Terminated
- Product code
- HQF
- Quantity affected
- 250 probes (25 boxes, each containing 10 probes)
- Distribution
- FL, IL, MD, CO and TX
- Date initiated
- 2010-07-27
- Date posted
- 2010-09-30
- Date terminated
- 2010-10-05
- Location
- Salt Lake City, UT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.