Device 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.
Z-2587-2017
Product summary
- Firm
- Teleflex Medical
- Event
- Event 77330
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 21,690 eaches
- Official record key
device-enforcement:Z-2587-2017
Official wording
Reason: Product size listed on the labeling is incorrect.
Code information: Product Code 5-15103 - Lot Number 73J1600218, 73K1600376, 73K1600587, 73L1600158, 73M1600275, 73A1700733;
Distribution pattern: 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
Derived failure modes
-
Labeling or packaging
labeling is incorrect