Halyard Health Recalls KimVent Wet Pak Closed Suction Systems
Halyard Health is recalling KimVent Wet Pak closed suction systems because a defect may cause air leaks.
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 leaks, representing a risk of harm where injury has not yet been reported, consistent with the 'High' severity criteria.
Plain-English summary
Halyard Health is recalling KimVent Wet Pak, Closed Suction Systems for Adults, Double Swivel Elbow, 14 Fr. Sterile, distributed by Kimberly Clark Global Systems, LLC. The recall involves 83 cases, with 20 tubes per case.
The recall was initiated because a hole or crack was found in the product, which may cause air to leak. The affected product codes are 22108147, with Wet Pak lot numbers AB4195U14, AB4216U06, and AB4230U16, and KimVent lot number M4132T643.
The products were distributed in California, Florida, Illinois, Louisiana, Massachusetts, Maryland, Minnesota, Mississippi, New Mexico, New York, Oklahoma, Texas, and Japan. Healthcare facilities and consumers should stop using the affected products and contact Halyard Health for instructions on return or replacement.
The recalled product
- Product
- KimVent Wet Pak, Closed Suction System for Adults, Double Swivel Elbow, 14 Fr. Sterile, Distributed by Kimberly Clark Global Systems, LLC.
- Manufacturer
- Halyard Health
- Category
- Medical Device — Suction Systems
- 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 (5)
- Product Code
- 22108147
- Wet Pak Lot number: AB4195U14
- AB4216U06 & AB4230U16
- KimVent Lot Number: M4132T643.
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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