RUSCH POLARIS" Laryngoscope - Product Usage: intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.
FDA Recall Z-1294-2021 · Posted None
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Recalling FirmTELEFLEX MEDICAL INC
Recall StatusTerminated
Product CodeCCW
Date Initiated2021-02-18
Date Terminated2026-08-31
Product Quantity157, 150 units (156,980 units in the US; 170 units OUS)
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.
Firm Action
The US consignee notification letter "Urgent Medical Device Recall Notification" and Recall Acknowledgement form sent on 02/18/2021 via FedEx 2-day mail.
Root Cause
Under Investigation by firm
Distribution Pattern
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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