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Terminated

Kimberly-Clark/Ballard TRACH CARE* - 72 Wet Pak* for Adults * Closed Suction System with Saline Vials * Diameter 14 Fr (4.6 mm), Length 30.5 cm (12 in) * Rx Only * Single Use * Manufactured by Ballard Medical Products, Draper, Utah 84020 USA, Distributed in the US by Kimberly-Clark Global Sales, Inc., Roswell, GA 30076 USA.

FDA Recall Z-0374-06 · Posted 2006-01-11

Recalling FirmKimberly-Clark Corporation
Recall StatusTerminated
Product CodeBSY
Date Initiated2005-11-30
Date Terminated2006-09-06
Product Quantity52 cases (20 units per case)

Reason for Recall

The integrity of the sterile unit package may become compromised.

Firm Action

Consignees were notified via certified mail, return receipt on 11/30/2005. The neonatal recall was faxed to the two consignees with a method to return product.

Root Cause

Other

Distribution Pattern

AL, AZ, CA, CO, FL, GA, IA, IL, KY, MD, MO, MN, NJ, NY, OH, OK, PA, RI, SD, TN, TX, UT, VA, WV, WY.

Official Source

View FDA Recall →

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

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