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Terminated

Custom surgical packs for a variety of surgical applications. Each pack is custom assembled and contains a variety of components including blades, gowns, needles, sponges, towels, syringes, gloves, etc. All products could have the WINDSTONE MEDICAL INC. label or the CARDIO-PAK label. MAJOR PACK

FDA Recall Z-0753-03 · Posted 2003-04-22

Recalling FirmWindstone Medical, Inc.
Recall StatusTerminated
Date Initiated2003-03-25
Date Terminated2003-09-09
Product Quantity8

Reason for Recall

Product has latex free symbol on package, yet contains latex components.

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K923231CARDIO-PAK BASIC PUMP PACKCardio-Med-Associates, Inc. · 1993-07-09K923233CARDIO-PAK LAPAROTOMY PACKCardio-Med-Associates, Inc. · 1993-03-20K902475CARDIO-PAK ANGIOGRAPHY CUSTOM PACKSCardio-Pak · 1990-12-03

Official Source

View FDA Recall →

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

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