Boston Scientific brand Nephroureteral Stent System. Contents: 1-8Fr percuflex catheter with stent and locking pigtail, 1-stiffening cannula and 1-luer cap with septum. REF/catalog no. 90-6885; model no. M001906885.
FDA Recall Z-1106-04 · Posted 2004-07-20
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Recalling FirmBoston Scientific Corp
Recall StatusTerminated
Product CodeGBO
Date Initiated2004-06-25
Date Terminated2004-08-23
Reason for Recall
Mislabeled as to size; 10FR are labeled as 8FR.
Firm Action
The firm hand delivered the recall notification to the consignee hospital on 6/30/04. Product at the customer have been relabeled by the firm.
Root Cause
Other
Distribution Pattern
Missouri.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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