Kimberly-Clark Corporation Kimberly-Clark/Ballard TRACH CARE* - 72 Closed Suction products for Adults, Rx Only * Sterile * Diameter 14 Fr (4.6 mm), 54 cm (21.3 in) * Single Use * Made in Mexico, Manufactured by Ballard Medical Products, Draper, Utah 84020 USA, Distributed in the US by Kimberly-Clark Global Sales, Inc., Roswell, GA 30076 USA. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Kimberly-Clark/Ballard TRACH CARE* - 72 Closed Suction products for Adults, Rx Only * Sterile * Diameter 14 Fr (4.6 mm), 54 cm (21.3 in) * Single Use * Made in Mexico, Manufactured by Ballard Medical Products, Draper, Utah 84020 USA, Distributed in the US by Kimberly-Clark Global Sales, Inc., Roswell, GA 30076 USA.
Brand
Kimberly-Clark Corporation
Lot Codes / Batch Numbers
Catalog number 227, Lot number 317128 & 317129
Products Sold
Catalog number 227, Lot number 317128 & 317129
Kimberly-Clark Corporation is recalling Kimberly-Clark/Ballard TRACH CARE* - 72 Closed Suction products for Adults, Rx Only * Sterile * Dia due to The integrity of the sterile unit package may become compromised.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The integrity of the sterile unit package may become compromised.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AZ, CA, CO, FL, GA, IL, IA, KY, MD, MN, MO, NJ, NY, OH, OK, PA, RI, SD, TN, TX, UT, VA, WV, WY
Page updated: Jan 10, 2026