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Recall Observatory FDA recall evidence

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

May 11, 2017

Class II

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

    reason.labeling_packaging · v1.0.0

    labeling is incorrect