Microflow Needles, catalog #DP8200, with 0 degree tapering, labeled in part ***Non-sterile, Manufactured for Bausch and
FDA device recall Z-1279-03 · posted 2003-10-15 · Terminated
Recall details
- Recalling firm
- Bausch & Lomb Incorporated
- Reason for recall
- The firm's DP8200 Microflow Needle Packs were labeled with the firm's DP8115 Phaco Needle Packs and visa versa.
- Action taken
- Firm notified customers by phone and letter 8/25/2003 and advised of needle mix-up. Customers were requested to quarantine affected product and return product with response form.
- Root cause
- Other
- Status
- Terminated
- Product code
- HQC
- Quantity affected
- 22 boxes
- Distribution
- Product was sold to 6 direct accounts in FL, IA, WI, MA and IL. Product was additionally sold to 4 international distributors.
- Date initiated
- 2003-08-25
- Date posted
- 2003-10-15
- Date terminated
- 2003-12-15
- Location
- Lynchburg, VA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STORZ MICROFLOW PHACOEMULSIFICATION NEEDLE (K954340) | Storz | 1995-12-14 |