Z-0589-03

Scimed ChoICE PT ''J'' Tip 182 cm Guide Wire, a single use, sterile (EO), device packaged in a carrier tube...

Name: Z-0589-03 Scimed ChoICE PT ''J'' Tip 182 cm Guide Wire, a single use, sterile (EO), device packaged in a carrier tube...
Creator: Symbiosis Corp.
Published: 2002-07-16
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2002-07-16 / Terminated / root cause: labeling and UDI

FDA source

Symbiosis Corp. began a recall of 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... on 2002-07-16. The reason FDA records is "Labeled as J tip but may be straight tip". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0589-03
Status: Terminated
Initiated: 2002-07-16
Posted: 2003-02-27
Terminated: 2008-04-15
Recalling firm: Boston Scientific Corporation
Product: 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.
Product code: DQX Wire, Guide, Catheter
Reason for recall: Labeled as J tip but may be straight tip.
Root cause tag: labeling and UDI
FDA 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 in commerce: 24 units
Distribution: Product was distributed to 7 hospital accounts in FL, KS, NH, IA, PA, MI AND CA.
Product codes and lots: 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.

Product code DQX

K962572Class IIScimed Choice Pt Vision Ptca Guide WireScimed Life Systems, Inc. / cleared 1996-12-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)