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Terminated

Violet Ink sterilization indicators Violet Ink (Class 6) and Violet Ink (Bowie Dick). Product numbers: CI 144, BD 115, PL 315, PL319, PL232, PL236, PL237, PL 238.

FDA Recall Z-1531-2010 · Posted 2010-04-29

Recalling FirmSteritec Products Mfc. Co., Inc.
Recall StatusTerminated
Product CodeJOJ
Date Initiated2009-07-15
Date Terminated2010-06-28
Product Quantity2656 cases

Reason for Recall

This action notifies affected SteriTec customers as well as private label distributors of the necessity to modify the shelf life of their sterilization indicator products. There is insufficient data on file to support the shelf life dating on the product labeling.

Firm Action

Notify accounts by e-mail and letter, offering to exchange product for product with revised expiration date. Products exhausted by proper expiration date need not be returned or relabeled. Questions are directed to the firm at (303) 660-4201.

Root Cause

Other

Distribution Pattern

Nationwide distribution: IL, MI, NY, OH, VA

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K083650EMU-GRAPH 4 EMULATOR, MODEL CI 144Steritec Products, Inc. · 2009-03-05K024293BOWIE-DICK MINI PAK, MODEL BD 115Steritec Products, Inc. · 2003-08-11

Official Source

View FDA Recall →

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

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