Ballard Medical Products Kimberly-Clark / Ballard TRACH-CARE* MAC (Multi Access Catheter) for Neonates. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Kimberly-Clark / Ballard TRACH-CARE* MAC (Multi Access Catheter) for Neonates.
Brand
Ballard Medical Products
Lot Codes / Batch Numbers
Catalog No: 1900, Lot Numbers:211006, 211830, 213674.
Products Sold
Catalog No: 1900, Lot Numbers:211006, 211830, 213674.
Ballard Medical Products is recalling Kimberly-Clark / Ballard TRACH-CARE* MAC (Multi Access Catheter) for Neonates. due to Incorrect plug was included in the multi access catheter pkg. When inserted in the 'Y' it may disengage, allowing a leak of ventilator gases.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Incorrect plug was included in the multi access catheter pkg. When inserted in the 'Y' it may disengage, allowing a leak of ventilator gases.
Recommended Action
Per FDA guidance
All consignees were notified by letter on 06/13/2003.
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 noticePage updated: Jan 10, 2026