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Terminated

SUBCLAVIAN PROCEDURE TRAY

FDA Recall Z-0772-03 · Posted 2003-04-22

Recalling FirmWindstone Medical, Inc.
Recall StatusTerminated
Date Initiated2003-03-25
Date Terminated2003-09-09
Product Quantity3500

Reason for Recall

Product contains latex, but not labeled as containing latex.

Firm Action

On 3/25/03 the firm contacted their customers by telephone. This was followed by a letter dated 3/25/03. Enclosed with the letter is a response form for the customer to fill out and return to the firm. Product is to be returned to the firm.

Root Cause

Other

Distribution Pattern

The firm distributed to 13 hospitals and medical facilities located in CO, IN, MI, MN, MT, UT, and WA.

Official Source

View FDA Recall →

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

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