Recall Z-1054-2015 ยท BSR Stylet, Tracheal Tube
Cardinal Health
Lubricated Intubating Stylet 6FR that is inserted into an endotracheal tube to facilitate intubation. This product is used in surgical or medical emergency facilities. Primarily used on infants and pediatric patients.
| Date | Feb 4, 2015 (initiated Dec 23, 2014) |
| Status | Terminated |
| Reason | A small piece of the stylet sheath has the potential to shear off upon removal of the stylet from the tracheal tube. |
| Root cause | Process control |
| Action | URGENT: PRODUCT RECALL letters dated December 23, 2014 were sent to all customers of record. The letters included instructions for customers to: 1) quarantine the affected product; 2) notify any customers whom you may have distributed the affected product to; 3) contact the appropriate Customer Service group to arrange for return and credit of any affected product in your inventory; and, 4) complete and return the enclosed Acknowledgement Form. Customers with questions about this recall can contact Cardinal Health Quality Systems at 800-292-9332. |
| Quantity | 104,432 stylets |
| Distribution | US: Nationwide (AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI, WV, WY) + District of Columbia + Guam + US Army Facility in South Korea |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.