—#155751

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.

FDA product code: BSR — Stylet, Tracheal Tube
Device class: Class 1
Medical specialty: Anesthesiology
Affected lot / code info: Product Code 5-15103 - Lot Number 73J1600218, 73K1600376, 73K1600587, 73L1600158, 73M1600275, 73A1700733;

Why it was recalled

Product size listed on the labeling is incorrect.

Root cause (FDA determination)

Labeling mix-ups

Action the firm took

Recall letters were sent to consignees on 5/11/2017 asking them to check inventory and immediately discontinue use of the product. The letter included a reply form to be returned. A separate letter was sent to distributors requesting that they conduct a sub-recall.

Recalling firm

Firm: Teleflex Medical
Address: 2917 Weck Dr, Research Triangle Park, North Carolina 27709-0186

Distribution

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

Timeline

Recall initiated: 2017-05-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #155751. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.