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Terminated

Boston Scientific Contour VL Injection Stent with Hydro Plus Coating, 6 FR (2.0 mm) x 22-30 cm (220-300mm), sterile, UPN: M0061856300. Ureteral stent.

FDA Recall Z-1238-06 · Posted 2006-07-13

Recalling FirmBoston Scientific Corp
Recall StatusTerminated
Product CodeFAD
Date Initiated2006-05-10
Date Terminated2006-11-01
Product Quantity29

Reason for Recall

Instructions on how to inject are not included in the package.

Firm Action

A letter dated 5/10/06 was sent to each consignee requesting that they discontinue use of, and return, the product.

Root Cause

Other

Distribution Pattern

New York and Pennsylvania.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K010002CONTOUR POLARIS URETERAL STENTBoston Scientific Corp · 2001-01-22

Official Source

View FDA Recall →

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

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