Reported Sep 9, 2015 · Terminated
KimVent* Closed Suction System for Adults, 12 F, T-Piece (Product Code 2155); KimVent* Closed Suction System for…
Halyard Health, 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: Halyard Health, Inc · 5405 Windward Pkwy · Alpharetta, GA · 30004-3894
Is this the product you have?
- KimVent* Closed Suction System for Adults, 12 F, T-Piece (Product Code 2155); KimVent* Closed Suction System for Adults, 14 F, T-Piece (Product Code 2205, 8169, 8248, 22015, 22025, 220125, 220135) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airway.
- Lot codes and dates
8 of 8 products
Products covered by this recall Model / number Product as published 2155M5166T402, M5166T622, M5166T631 2205M5079T606, M5086T603, M5089T612, M5089T632, M5110T611, M5110T626, M5166T642 8169M5103T608 8248M5082T632 22015M5082T603, M5089T609, M5096T607 22025M5082T627, M5096T603 220125M5082T617, M5096T608 220135M5054T619, M5079T604, M5082T620, M5089T614, M5096T622 - Amount recalled
- 19,250 cases
This recall covers 32 products
The agency filed one notice per product. You are reading one of them; the other 31 are below.
19 more are in the archive.
Where it was sold
- Nationwide
- PR
Why it was recalled
The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position.
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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