Manual Biopsy Devices containing AIM system: Crown Biopsy Needle: 6 inch/15 cm, 22 gauge, Cat. #40-404, Material #M00140
FDA device recall Z-1444-04 · posted 2004-09-14 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- Incomplete graduation on the needle guard, which would cause the graduations to be off by as much as 1 cm.
- Action taken
- Letters dated 8/9/04 hand delivered by Boston Scientific Sales Representatives. Sales Reps will visit each consignee and assist customers in locating affected units and will place a sticker label on each unit.
- Root cause
- Other
- Status
- Terminated
- Product code
- KNW
- Quantity affected
- 22 cartons x 10 units
- Distribution
- Products sold to 53 medical facilities nationwide and one consignee in Italy.
- Date initiated
- 2004-08-09
- Date posted
- 2004-09-14
- Date terminated
- 2005-10-26
- Location
- Natick, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HYPODERMIC NEEDLES & STYLETS (K840033) | Microvasive | 1984-04-05 |