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Terminated

Cook Urological, Inc. Koyle Diaper Stent 6.0 Fr, Sterile, GPN G17667, REF KDSCF-060050.

FDA Recall Z-0966-2011 · Posted 2011-01-25

Recalling FirmVance Products Inc. dba Cook Urological Inc. & Cook OB/GYN
Recall StatusTerminated
Product CodeKOD
Date Initiated2010-12-13
Date Terminated2011-01-31
Product Quantity25 stents

Reason for Recall

The firm received a complaint that 15 units of the Koyle Diaper Stent were received in packages that had not been sealed. Each stent should be sealed in a poly-Tyvek pouch.

Firm Action

The firm sent an URGENT RECALL NOTICE to one consignee on 12/13/2010 (the other consignee returned all their product as a complaint). The letter informed the consignee of the recall and asked the customer to return the recalled product.

Root Cause

Packaging process control

Distribution Pattern

CA, CT

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K820313VPI-FAIR URETHRAL STENTVance Products, Inc. · 1982-03-01

Official Source

View FDA Recall →

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

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