Reported Feb 18, 2015 · Terminated
AQUA 540 SW, 540 W/040 ADAPTOR. Product Usage: The Humidifier Adaptor is an accessory which allows connection of…
Teleflex Medical
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 · 2917 Weck Dr · Research Triangle Park, NC · 27709-0186
Is this the product you have?
AQUA 540 SW540 W/040 ADAPTOR
- Product UsageThe Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall
- Lot codes and dates
- Product Code005-40
- Lot numbers
005135015135017135029135010135035135006145003135018135034135019135023135028135010145004145008135009145002145030135002135031135016135022135026135021135008145032135007135004135007145009135027135001145005145012135006135020135033135013135001135011135036135025135014135 & 003145
- Amount recalled
- 15,779,607 units
This recall covers 18 products
The agency filed one notice per product. You are reading one of them; the other 17 are below.
5 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
The packages may contain foreign material (black particles).
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
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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