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Terminated

Ultrakleen KSponge II Spears Catalog #: K20-5012

FDA Recall Z-0487-03 · Posted 2003-01-30

Recalling FirmUltracell Medical Technologies
Recall StatusTerminated
Product CodeHOZ
Date Initiated2003-01-08
Date Terminated2012-05-01
Product Quantity4,047 units

Reason for Recall

Sterility of the device is compromised

Firm Action

Ultracell Medical Technologies initiated the recall by fax or mail on 1/8/03. The firm requested return of product . Distributors were requestd to recall to their accounts.

Root Cause

Other

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K923922SURGICAL SPEARSUltracell Medical Technologies, Inc. · 1993-03-19

Official Source

View FDA Recall →

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

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