Recall Z-0374-06 ยท BSY Catheters, Suction, Tracheobronchial
Kimberly-Clark Corporation
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.
| Date | Jan 11, 2006 (initiated Nov 30, 2005) |
| Status | Terminated |
| Reason | The integrity of the sterile unit package may become compromised. |
| Root cause | Other |
| 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. |
| Quantity | 52 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.