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Recall Observatory FDA recall evidence

Device 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.

Z-1054-2015

December 23, 2014

Class II

Product summary

Firm
Cardinal Health
Event
Event 70185
Status
Terminated
Classification
Class II
Quantity
104,432 stylets
Official record key
device-enforcement:Z-1054-2015

Official wording

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

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

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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