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.
This recall has been terminated (originally issued February 27, 2003).
- Company
- Symbiosis Corp.
- Recall Initiated
- July 16, 2002
- Posted
- February 27, 2003
- Terminated
- April 15, 2008
- Recall Number
- Z-0589-03
- Quantity
- 24 units
- Firm Location
- Miami, FL
- Official Source
- View on FDA website ↗
Reason for Recall
Labeled as J tip but may be straight tip.
Distribution
Product was distributed to 7 hospital accounts in FL, KS, NH, IA, PA, MI AND CA.
Lot / Code Info
Pouch codes are:Catalog No. 12160-01J, UPN H7491216001J1, batch 4536936, expiration date of 2004-01. The five pack box codes are: Catalog No. 12160-01J, UPN H7491216001J2, batch 4562262, expiration date 2004-01.
Root Cause
Other
Action Taken
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.
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