Reported Jun 26, 2019 · Terminated
Hudson RCI Sheridan: 1) Uncuffed 6.0 mm, Product Code 5-10412 2) Uncuffed 6.5 mm, Product Code 5-10413 3) Uncuffed 7.0…
Teleflex Medical
High riskUsing this product could cause serious injury, illness or death — stop using it now.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 · 3015 Carrington Mill Blvd · Morrisville, NC · 27560-5437
Is this the product you have?
- Hudson RCI Sheridan
1) Uncuffed 6.0 mmProduct Code 5-10412 2) Uncuffed 6.5 mmProduct Code 5-10413 3) Uncuffed 7.0 mm
- Product Code 5-10414 Product UsageTracheal tube/airway management
- Lot codes and dates
3 of 3 products
Products covered by this recall Model / number Product as published 5-10412Uncuffed 6.0 mm, Lot Numbers: 73J1600363 73K1600581 73L1600347 73L1600552 73L1600850 73M1600138 73A1700264 73B1700300 73C1700688 73E1700098 73E1700712 73G1700132 73H1700327 73J1700290 73K1700065 73K1700415 73L1700169 73L1700320 73M1700250 73A1800060 73B1800348 73B1800487 73C1800349 73C1800482 73D1800464 73E1800389 73F1800171 73G1800923 5-10413Uncuffed 6.5 mm, Lot Numbers: 73M1600139 73B1700301 73E1700472 73G1700127 73K1700416 73A1800061 73B1800349 73B1800488 73D1800634 73F1800544 73G1800924 5-10414Uncuffed 7.0 mm, Lot Numbers: 73A1700100 73F1700064 73L1800406 - Amount recalled
- 14357
This recall covers 8 products
The agency filed one notice per product. You are reading one of them; the other 7 are below.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product) indicating that there is an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the Endotracheal tube.
Using this product could cause serious injury, illness or death — stop using it now.
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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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