Z-2587-2017 Class II Ongoing
FDA device recall Z-2587-2017 was initiated by Teleflex Medical on May 11, 2017 and is designated Class II. Reason for recall: Product size listed on the labeling is incorrect. The recall status is ongoing. Affected quantity: 21,690 eaches.
Recall Details
- Product Type
- Devices
- Report Date
- June 21, 2017
- Initiation Date
- May 11, 2017
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 21,690 eaches
Product Description
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 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
Code Information
Product Code 5-15103 - Lot Number 73J1600218, 73K1600376, 73K1600587, 73L1600158, 73M1600275, 73A1700733;