FDA recall Z-2587-2017

Product

Sheridan SHER-I-SLIP and SOFT-TIP Intubating Stylets are intubating stylets manufactured from galvanized carbon steel and aluminum rods that are coated with a blue PVC or polypropylene outer covering and are designed to be placed inside an endotracheal tube to obtain a desired shape during intubation.

Reason for recall

Product size listed on the labeling is incorrect.

Distribution

Worldwide Distribution - US Nationwide in the states of CT, FL, ID, IN, KY, MA, MI, MN, MO, NE, NJ, NY, NC, OH, PA, RI, SD, TX, UT, WA and countries of Canada, Czech Republic, Denmark, Germany, Israel, & Portugal

Key facts

Status

Ongoing

Initiation date

2017-05-11

Report date

2017-06-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Research Triangle Park, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2587-2017