Kimberly-Clark/Ballard TRACH CARE Wet Pack * Y Adapter * Closed Suction System for Neonates * Rx Only * 8 Fr (2.66 mm) * 30.5 cm (12 in) * 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
This recall has been terminated (originally issued January 11, 2006).
- Company
- Kimberly-Clark Corporation
- Recall Initiated
- November 30, 2005
- Posted
- January 11, 2006
- Terminated
- September 6, 2006
- Recall Number
- Z-0375-06
- Quantity
- 25 cases (20 units per case)
- Firm Location
- Roswell, GA
- Official Source
- View on FDA website ↗
Reason for Recall
The integrity of the sterile unit package may become compromised.
Distribution
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.
Lot / Code Info
Catalog number 8213, Lot Number 309962
Root Cause
Other
Action Taken
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.
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