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Terminated

Pursuit ureteral dilation balloon catheters, 6 mm x 8 cm. Order # PAB-050080-6-8.0

FDA Recall Z-0555-03 · Posted 2003-02-13

Recalling FirmCook Urological, Inc.
Recall StatusTerminated
Product CodeEZN
Date Initiated2003-01-22
Date Terminated2003-03-26
Product Quantity9

Reason for Recall

Product is labeled sterile, but was not sterilized.

Firm Action

Customers were notified by phone call and recall letter beginning on 1/22/03.

Root Cause

Other

Distribution Pattern

Alaska, Hawaii, Minnesota, Ohio, Tennessee and Ireland.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K990072BALLOON URETERAL DILATORS, ACCENT DG BALLOON URETERAL DILATOR SET, ASCEND BALLOON DILATION CATHETERS, BALLOON DILATION CCook Urological, Inc. · 1999-03-25

Official Source

View FDA Recall →

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

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