Keeler All Pupil II Indirect Ophthalmoscope, Keeler Instruments, Inc., Broomall, PA 19008
FDA device recall Z-1132-2008 · posted 2008-05-22 · Terminated
Recall details
- Recalling firm
- Keeler Instruments Inc
- Reason for recall
- Good Manufacturing Practices (GMP) deficiencies may compromise the safety and effectiveness of the device. Firm is on import alert 89-04 and released product.
- Action taken
- Keeler Instruments issued an email dated 1/8/08 to the distributor requesting that they return the product.
- Root cause
- Process design
- Status
- Terminated
- Product code
- HLI
- Quantity affected
- 25 units
- Distribution
- The products were shipped to a distributor in NJ.
- Date initiated
- 2008-01-08
- Date posted
- 2008-05-22
- Date terminated
- 2008-08-12
- Location
- Broomall, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| THE KEELER ALL PUPIL INDIRECT OPHTHALMOSCOPE (K854244) | Keeler Instruments, Inc. | 1985-11-12 |