Scimed ChoICE PT Extra Support PTCA Guide Wire with ICE Hydrophilic Coating, 300 cm length
FDA device recall Z-0590-03 · posted 2003-02-27 · Terminated
Recall details
- Recalling firm
- Symbiosis Corp.
- Reason for recall
- Product labeled as Scimed ChoICE PT Extra Suport PTCA Guide Wire 300 cm were actually Scimed PT Graphix Intermediate PTCA Guide Wire 300 cm
- Action taken
- Recall letters with response forms were sent to hosptials via FED EX on 8/22/02. Product was to be returned to Boston Scientific in Quincy, MA.
- Root cause
- Other
- Status
- Terminated
- Product code
- DQX
- Quantity affected
- 27/5 pack boxes
- Distribution
- Recalled product was shipped to 107 domestic hosptials nationwide and to 2 international acccounts.
- Date initiated
- 2002-08-22
- Date posted
- 2003-02-27
- Date terminated
- 2012-07-13
- 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 EXCHANGE EXTRA SUPPORT PTCA AND LONG TAPER PTCA GUIDE WIRE (K960657) | Scimed Life Systems, Inc. | 1996-04-29 |