FDA Recall
Terminated
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.
Recall: Z-0589-03
·
Initiated July 16, 2002
Recall
- Recall Number
- Z-0589-03
- Event Number
- 25500
- Firm
- Symbiosis Corp.
- FEI Number
- 1051710
- Product Code
- DQX
- Status
- Terminated
- Root Cause
- Other
- Initiated
- July 16, 2002
- Posted
- February 27, 2003
- Terminated
- April 15, 2008
- Address
- 8600 NW 41th Street, Miami, FL, 33166
Description
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.
Reason
Labeled as J tip but may be straight tip.
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.
Distribution
Product was distributed to 7 hospital accounts in FL, KS, NH, IA, PA, MI AND CA.
Quantity
24 units