Scimed ChoICE PT ''J'' Tip 182 cm Guide Wire, a single use, sterile (EO), device packaged in a carrier tube, which is he
FDA device recall Z-0589-03 · posted 2003-02-27 · Terminated
Recall details
- Recalling firm
- Symbiosis Corp.
- Reason for recall
- Labeled as J tip but may be straight tip.
- Action taken
- The firm notified all user/hospital accounts via a 7/16/2002 letter sent via FEDEX along with a response form. Accounts were to return any recalled product.
- Root cause
- Other
- Status
- Terminated
- Product code
- DQX
- Quantity affected
- 24 units
- Distribution
- Product was distributed to 7 hospital accounts in FL, KS, NH, IA, PA, MI AND CA.
- Date initiated
- 2002-07-16
- Date posted
- 2003-02-27
- Date terminated
- 2008-04-15
- Location
- Miami, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SCIMED CHOICE PT VISION PTCA GUIDE WIRE (K962572) | Scimed Life Systems, Inc. | 1996-12-17 |