Recall Z-0592-03 ยท DQX Wire, Guide, Catheter
Symbiosis Corp.
Product is a ChoICE 182 cm Guide Wire, intended to facilitate placement of balloon dilatation catheters and other therapeutic devices during Percutaneous Transluminal Coronary Angioplasty (PTCA) procedures. The ChoICE guide wire contains a one-piece stainless steel core, which extends throughout the length of the wire and provides steerability and torqueability. The wire is tapered and formed at
| Date | Feb 27, 2003 (initiated Nov 19, 2002) |
| Status | Terminated |
| Reason | Product is mislabled as a ChoICE Floppy Guide Wire when it is actually a ChoICE ES(Extra Support) Guide Wire. |
| Root cause | Other |
| Action | Recall Letters issued 11/19/2002 via Federal Express to 7 hospital accounts. Consignees were requested to fill out a response form and return product to their Quincy, MA facility. |
| Quantity | 19/5-pack units |
| Distribution | Product was distributed to hospitals in FL, MI, GA, OR, ID AND CT. 05. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K962572 | SCIMED CHOICE PT VISION PTCA GUIDE WIRE Scimed Life Systems, Inc., Dec 17, 1996 |