Z-1054-2015 Class II Terminated
FDA device recall Z-1054-2015 was initiated by Cardinal Health on Dec 23, 2014 and is designated Class II. 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. The recall status is terminated (terminated Aug 1, 2016). Affected quantity: 104,432 stylets.
Recall Details
- Product Type
- Devices
- Report Date
- Feb 11, 2015
- Initiation Date
- Dec 23, 2014
- Termination Date
- Aug 1, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 104,432 stylets
Product Description
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.
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.
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
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1054-2015
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026