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Terminated

Stretta brand Catheter and Accessory Kit, Part # 175-2575. Model 4301K

FDA Recall Z-0663-03 · Posted 2003-03-20

Recalling FirmCuron Medical Inc
Recall StatusTerminated
Product CodeDQO
Date Initiated2003-02-21
Date Terminated2003-04-21

Reason for Recall

Catheter shaft has potential to crack during use.

Firm Action

On 2/21/03 the firm initiated the recall and its notification was via letters to inform its consignees about the problem with its catheters. It requests immediate discontinuance of all product with certain lot numbers.

Root Cause

Other

Distribution Pattern

Product was released for distribution to 52 direct accounts nationwide including 1 VA Medical Center, Endoscopy Dept., 150 S. Huntington Ave., Boston, MA 02130, ATTN: Dr. Hiroshi Mashimo, ph#: 617-363-5640.

Official Source

View FDA Recall →

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

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