Recall Z-0589-03 ยท DQX Wire, Guide, Catheter
Symbiosis Corp.
Scimed ChoICE PT ''J'' Tip 182 cm Guide Wire, a single use, sterile (EO), device packaged in a carrier tube, which is held in a coil by plastic clips. The carrier tube assembly of the guide wire is sealed into a pouch. The pouch assembies are packaged in a five-pack product box.
| Date | Feb 27, 2003 (initiated Jul 16, 2002) |
| Status | Terminated |
| Reason | Labeled as J tip but may be straight tip. |
| Root cause | Other |
| Action | 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. |
| Quantity | 24 units |
| Distribution | Product was distributed to 7 hospital accounts in FL, KS, NH, IA, PA, MI AND CA. |
| 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 |