Prostate Biopsy Needle, Model: NAC-1825BB, Soxe 18 GA x 25 CM, Single use, Ethylene sterilized, Non-pyrogenic, Remington
FDA device recall Z-0673-2007 · posted 2007-03-29 · Terminated
Recall details
- Recalling firm
- Remington Medical Inc.
- Reason for recall
- Pouches were not sealed prior to sterilization.
- Action taken
- Consignees were contacted by telephone on 01/19/2007. Each customer was informed the sterility of the product may be compromised as a result of unsealed pouches and requested to visually check their inventory.
- Root cause
- Other
- Status
- Terminated
- Product code
- KNW
- Quantity affected
- 192 units
- Distribution
- Nationwide.
- Date initiated
- 2007-01-19
- Date posted
- 2007-03-29
- Date terminated
- 2007-05-11
- Location
- Alpharetta, GA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PROSTATE BIOPSY NEEDLE (K982401) | Remington Medical, Inc. | 1998-09-08 |