Recall Z-0591-03 ยท DQX Wire, Guide, Catheter
Symbiosis Corp.
Scimed PT Graphix Intermediate PCTA Guide Wire with ICE Hydrophilic Coating, 300 cm length.
| Date | Feb 27, 2003 (initiated Aug 22, 2002) |
| Status | Terminated |
| Reason | Product labeled as Scimed ChoICE PT Extra Suport PTCA Guide Wire 300 cm were actually Scimed PT Graphix Intermediate PTCA Guide Wire 300 cm |
| Root cause | Other |
| Action | 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. |
| Quantity | 228/5 pack boxes |
| Distribution | Recalled product was shipped to 107 domestic hosptials nationwide and to 2 international acccounts. |
| 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 |