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Terminated

Medi-Tech Magic Torque Glidex hydrophilic coated guidewire, .035 inch/180 cm and .035 inch/260 cm lengths. Packaged in a sterile pouch and a three pack shelf box.

FDA Recall Z-0666-03 · Posted 2003-03-20

Recalling FirmSymbiosis Corp.
Recall StatusTerminated
Product CodeDQX
Date Initiated2002-11-27
Date Terminated2012-07-13
Product Quantity286

Reason for Recall

The 180 cm guidewire is mislabeled as 260 cm and the 260 cm guidewire is mislabeled as 180 cm.

Firm Action

A Recall Notification Letter was send to hospitals via Federal Express Overnight Delivery, on 11/27/2002 to the attention of the Risk Manager and the Cath Lab Manager. In addition a response form was included. Recalled units are to be returned to the Boston Scientific Distribution Center located at 500 Commander Shea Blvd., Quincy, MA 02171.

Root Cause

Other

Distribution Pattern

Product was distributed to 118 hospitals nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K933334MAGIC TORQUE GUIDEWIREBoston Scientific Corp · 1994-01-26

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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