FDA Recall
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.
Recall: Z-0374-06
·
Initiated November 30, 2005
Recall
- Recall Number
- Z-0374-06
- Event Number
- 34218
- Firm
- Kimberly-Clark Corporation
- FEI Number
- 1000015879
- Product Code
- BSY
- Status
- Terminated
- Root Cause
- Other
- Initiated
- November 30, 2005
- Posted
- January 11, 2006
- Terminated
- September 6, 2006
- Address
- 1400 Holcomb Bridge Rd, Roswell, GA, 30076
Description
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.
Reason
The integrity of the sterile unit package may become compromised.
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.
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.
Quantity
52 cases (20 units per case)