Recall Z-1294-2021
Teleflex Medical Inc · initiated February 18, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
RUSCH POLARIS" Laryngoscope - Product Usage: intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.
Codes / lots: Model 44401 (GTIN: Each: 14026704662552 Box: 24026704662559 Case: 34026704662556; lots 197, 19A, 19F, 19J, 19P, 19W, 205, 207, 20C, 20H, 20T); Model 44402 (GTIN: Each: 14026704662569 Box: 24026704662566 Case: 34026704662563; lots 197, 19A, 19F, 19J, 19P, 19W, 205, 207, 20C, 20H, 20M, 20T); Model 44403 (GTIN: Each: 14026704662576 Box: 24026704662573 Case: 34026704662570; lots 197, 19A, 19F, 19J, 207, 20C, 20H, 20M, 20T).
Reason for recall
Teleflex is voluntarily recalling the products referenced above due to customers reporting that the laryngoscope handles develop cracks and/or break at the hinge.
FDA-determined cause: Under Investigation by firm
Action taken
The US consignee notification letter "Urgent Medical Device Recall Notification" and Recall Acknowledgement form sent on 02/18/2021 via FedEx 2-day mail.
Details
- Recall number
- Z-1294-2021
- Initiated
- February 18, 2021
- Product code
- CCW – Laryngoscope, Rigid
- Quantity
- 157, 150 units (156,980 units in the US; 170 units OUS)
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI. The country of Canada.
- Recalling firm
- Teleflex Medical Inc, Morrisville, NC