Z-2728-2020 Class II Terminated
FDA device recall Z-2728-2020 was initiated by TELEFLEX MEDICAL INC on July 6, 2020 and is designated Class II. Reason for recall: Breaking at the point of a welded joint The recall status is terminated (terminated August 31, 2023). Affected quantity: 7401 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 5, 2020
- Initiation Date
- July 6, 2020
- Termination Date
- August 31, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7401 units
Product Description
Rusch Greenlite Product Code: 004550004 GTIN: 14026704663085 (each) - Product Usage: The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.
Reason for Recall
Breaking at the point of a welded joint
Distribution Pattern
US Nationwide distribution including in the states of FL, KY, CA, ND, UT, MA, MD, AZ, MS, TX, MI, WV, AL, MO, SC, VA, AR, PA, OK, NV, NM, NE, IN, IA, NY, GA, NJ, MN, IL, NC, NH, TN, ID, CO, HI, MT, OR, ME, CT, LA, OH, RI, SD, WA, DC, KS, AK.
Code Information
Lot/Batch Numbers: 1812441 1901441 1903441 1905441 1906441 1907441 1909441