RUSCH¿ POLARIS" Laryngoscope - Product Usage: intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.
Reported: March 31, 2021 Initiated: February 18, 2021 #Z-1294-2021
Product Description
RUSCH¿ POLARIS" Laryngoscope - Product Usage: intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.
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.
Details
- Recalling Firm
- TELEFLEX MEDICAL INC
- Units Affected
- 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.
- Location
- Morrisville, NC
Frequently Asked Questions
What product was recalled? ▼
RUSCH¿ POLARIS" Laryngoscope - Product Usage: intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.. Recalled by TELEFLEX MEDICAL INC. Units affected: 157, 150 units (156,980 units in the US; 170 units OUS).
Why was this product recalled? ▼
Teleflex is voluntarily recalling the products referenced above due to customers reporting that the laryngoscope handles develop cracks and/or break at the hinge.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 31, 2021. Severity: Moderate. Recall number: Z-1294-2021.
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