Reported Mar 31, 2021 · Ongoing
RUSCH¿ POLARIS" Laryngoscope - Product Usage: intended to allow direct visualization of the laryngeal structure and is…
Teleflex Medical Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: TELEFLEX MEDICAL INC · 3015 Carrington Mill Blvd · Morrisville, NC · 27560-5437
Is this the product you have?
- RUSCH¿ POLARIS"
- Laryngoscope - Product Usageintended to allow direct visualization of the laryngeal structure and is used during tracheal intubation
- Lot codes and dates
6 of 6 products
Products covered by this recall Model / number Barcodes Product as published 44401140267046625522402670466255934026704662556(GTIN: Each: 14026704662552 Box: 24026704662559 Case: 34026704662556 — lots 197, 19A, 19F, 19J, 19P, 19W, 205, 207, 20C, 20H, 20T) 44402140267046625692402670466256634026704662563(GTIN: Each: 14026704662569 Box: 24026704662566 Case: 34026704662563 — lots 197, 19A, 19F, 19J, 19P, 19W, 205, 207, 20C, 20H, 20M, 20T) 44403140267046625762402670466257334026704662570(GTIN: Each: 14026704662576 Box: 24026704662573 Case: 34026704662570 — lots 197, 19A, 19F, 19J, 207, 20C, 20H, 20M, 20T). - Amount recalled
- 157, 150 units (156,980 units in the US; 170 units OUS)
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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