Kimberly-Clark/Ballard TRACH CARE Wet Pack * Y Adapter * Closed Suction System for Neonates * Rx Only * 8 Fr (2.66 mm) *
FDA device recall Z-0375-06 · posted 2006-01-11 · Terminated
Recall details
- Recalling firm
- Kimberly-Clark Corporation
- Reason for recall
- The integrity of the sterile unit package may become compromised.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- BSY
- Quantity affected
- 25 cases (20 units per case)
- 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.
- Date initiated
- 2005-11-30
- Date posted
- 2006-01-11
- Date terminated
- 2006-09-06
- Location
- Roswell, GA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.