Halyard Health Recalls KimVent Closed Suction Systems Due to Defects
Halyard Health is recalling KimVent Closed Suction Systems for Adults because a hole or crack was found that may cause air to leak.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the defect (air leak) presents a risk of harm to patients using the medical device, though no specific injuries or illnesses are reported in the source text.
Plain-English summary
Halyard Health is recalling KimVent Closed Suction Systems for Adults, Double Swivel Elbow, 12 Fr., Sterile, distributed by Kimberly Clark Global Systems, LLC. The recall involves 5 cases, with 20 tubes per case. The product is identified by Product Code 2160 and Lot number M4132T636.
The recall was initiated because a hole or crack was found in the product, which may cause air to leak. This defect is classified as Class II by the U.S. Food and Drug Administration.
The affected products were distributed in California, Florida, Illinois, Louisiana, Massachusetts, Maryland, Minnesota, Mississippi, New Mexico, New York, Oklahoma, Texas, and Japan. Consumers and healthcare facilities should stop using the affected units and contact Halyard Health for further instructions.
The recalled product
- Product
- KimVent Closed Suction System for Adults, Double Swivel Elbow, 12 Fr., Sterile, Distributed by Kimberly Clark Global Systems, LLC.
- Manufacturer
- Halyard Health
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Product Code
- 2160
- Lot number: M4132T636
Distribution
Part of a larger recall action
This product is one of 3 recalled by Halyard Health under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Halyard Health
See all →- ModerateHalyard Health Recalls Sterling Nitrile Sterile Exam Gloves Due to Defects
FDA (Devices) · 2016-12-21
- HighHalyard Health Recalls KimVent Closed Suction Systems Due to Air Leak Defect
FDA (Devices) · 2015-03-11
- HighHalyard Health Recalls KimVent Wet Pak Closed Suction Systems
FDA (Devices) · 2015-03-11
- HighHalyard Health Recalls KimVent Microcuff Endotracheal Tubes Due to Detachment Risk
FDA (Devices) · 2014-12-31
- HighHalyard Health Recalls KimVent Microcuff Endotracheal Tubes Due to Detachment Risk
FDA (Devices) · 2014-12-31
Same hazard · air leak
See all →- HighBeckman Coulter Analyzer Recalled for Pneumatic Tubing Defects
FDA (Devices) · 2024-09-25
- High2021 International RH and LT Vehicles Parking Brake Defect
NHTSA · 2021-04-01
- High2021 Mazda Mazda3 and CX-30 tire air valve failure recall
NHTSA · 2021-02-22
- HighIntuitive Surgical Recalls daVinci XI Sureform 60 Reloads Due to Staple Deployment Issues
FDA (Devices) · 2020-05-13
- HighIntuitive Surgical Recalls daVinci XI Sureform Stapler Reloads Due to Deployment Defect
FDA (Devices) · 2020-05-13