—#132452

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.

FDA product code: BSR — Stylet, Tracheal Tube
Device class: Class 1
Medical specialty: Anesthesiology
Affected lot / code info: 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

Why it was recalled

A small piece of the stylet sheath has the potential to shear off upon removal of the stylet from the tracheal tube.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Cardinal Health
Address: 1300 Waukegan Rd, Waukegan, Illinois 60085-6724

Distribution

Distribution pattern: 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

Timeline

Recall initiated: 2014-12-23
Posted by FDA: 2015-02-04
Terminated: 2016-08-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #132452. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.