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U.S. Department of Health and Human Services

Class 2 Device Recall Cardinal Health Lubricated Intubating Stylet

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  Class 2 Device Recall Cardinal Health Lubricated Intubating Stylet see related information
Date Initiated by Firm December 23, 2014
Date Posted February 04, 2015
Recall Status1 Terminated 3 on August 01, 2016
Recall Number Z-1054-2015
Recall Event ID 70185
Product Classification Stylet, tracheal tube - Product Code BSR
Product 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.
Code Information Material Number: ISL6; Lot Numbers: 1409LS45A-SH, 1408LS41A-SH, 1406LS22A-SH, 1404LS14A-SH, 1310LS23A-SH, 1310LS21A-SH, 1308LS17A-SH, 1307LS14A-SH, 1303LS04A-SH, 1204LS03A-SH, 1110LS10A-SH, 1111LS11A-SH, 1107LS07A-SH, 1106LS06A-SH, 1104LS04A-SH, 1105LS05A-SH, 1003020386-SH, 912022138-SH, 910021815-SH, 907021095-SH
Recalling Firm/
Manufacturer		 Cardinal Health
1300 Waukegan Rd
Waukegan IL 60085-6724
For Additional Information Contact Cardinal Health Quality Systems
800-292-9332
Manufacturer Reason
for Recall		 A small piece of the stylet sheath has the potential to shear off upon removal of the stylet from the tracheal tube.
FDA Determined
Cause 2		 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 in Commerce 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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