Ocular Conformer, Sterile, Porex Surgical Inc., 15 Dart Road, Newnan, GA 30265. The device is intended to be used as a p
FDA device recall Z-2302-2008 · posted 2008-09-20 · Terminated
Recall details
- Recalling firm
- Porex Surgical, Inc.
- Reason for recall
- The Ocular Conformers were distributed with an expired expiration date.
- Action taken
- Consignees were contacted by phone on 03/28/2008. A follow up letter was sent on/about 03/31/2008. Consignees were instructed to examine their inventory and to quarantine Ocular Conformers containing the affected lots. These units should be returned to Porex Surgical using a Return Authorization Number provided. If the units were distributed, consignees were advised to contact their customers and inform them of the recall. They were informed the recall was being conducted to the physician level. Contact Porex Surgical at 1-770-515-7735 for assistance.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- HQN
- Quantity affected
- 9 units
- Distribution
- PA, Canada and Germany
- Date initiated
- 2008-03-28
- Date posted
- 2008-09-20
- Date terminated
- 2008-10-10
- Location
- Newnan, GA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MEDPOR OCULAR CONFORMER (K972034) | Porex Surgical, Inc. | 1998-01-20 |