Boston Scientific vanSonnenberg Sump with ''J'' Tip, 30 cm, 14Fr (4.7 mm), for percutaneous abscess and fluid drainage, single use only, sterile; UPN M001202010, REF/Catalog No. 20-201.
FDA Recall Z-1499-06 · Posted 2006-09-13
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Recalling FirmBoston Scientific Corp
Recall StatusTerminated
Product CodeGBW
Date Initiated2006-08-10
Date Terminated2007-02-07
Product Quantity4 units
Reason for Recall
Lack of assurance of sterility, as the sterile barrier is weak and may be damaged on one edge.
Firm Action
Consignee was notified via letter 8/10/06 to discontinue use of the product and to return it to the firm.
Root Cause
Other
Distribution Pattern
Texas.
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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