Baxter 15L Cycler Drainage Bags Recalled for Inlet Port Leakage
Baxter Healthcare Corp. is recalling 19,440 units of 15L Cycler Drainage Bags due to leakage from the inlet port. The products were distributed in the US and Canada.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 (leakage) that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Baxter Healthcare Corp. is recalling 19,440 units of Baxter 15L Cycler Drainage Bags, Sterile, nonpyrogenic fluid path. The recall is due to leakage from the inlet port of the bags.
The affected products were distributed in the United States and internationally to Canada. The specific code for the recalled units is H15C11095.
Consumers should stop using the affected drainage bags and contact Baxter Healthcare Corp. for further instructions or a replacement.
The recalled product
- Product
- Baxter 15L Cycler Drainage Bag Sterile, nonpyrogenic fluid path
- Manufacturer
- Baxter Healthcare Corp.
- Category
- Medical Device — Drainage Bags
- Hazard
- Affected units
- 19,440
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 (1)
- H15C11095
Distribution
Distribution scope not specified by the agency.
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