Halyard Health Recalls KimVent Closed Suction Systems Due to Air Leak Defect
Halyard Health is recalling KimVent Closed Suction Systems for Adults because a hole or crack may cause air to leak. The recall affects 5 cases distributed to specific US states and Japan.
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 involves a medical device with a defect that may cause air to leak, representing a risk-of-harm product where injury has not yet been reported, consistent with the High severity criteria.
Plain-English summary
Halyard Health is recalling KimVent Closed Suction Systems for Adults, Double Swivel Elbow, 14 Fr. Sterile, distributed by Kimberly Clark Global Systems, LLC. The recall involves 5 cases, containing 20 tubes per case, with Product Code 22103 and Lot number M4132T614.
The recall was initiated because a hole or crack was found in the product, which may cause air to leak. This defect could compromise the integrity of the closed suction system.
The affected products were distributed to California, Florida, Illinois, Louisiana, Massachusetts, Maryland, Minnesota, Mississippi, New Mexico, New York, Oklahoma, Texas, and Japan. Consumers and healthcare facilities should check their inventory for the specific product code and lot number listed above and stop using the affected units if found.
The recalled product
- Product
- KimVent Closed Suction System for Adults, Double Swivel Elbow, 14 Fr. Sterile, Distributed by Kimberly Clark Global Systems, LLC.
- Manufacturer
- Halyard Health
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
- 22103
- Lot number: M4132T614
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.
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