Baxter Recalls Vented Spike Adapters Due to Potential Pouch Tears
Baxter Healthcare is recalling 49,344 units of Vented Spike Adapters because potential tears in the pouch could compromise sterility.
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 (potential tears) that could compromise sterility, posing a risk of harm to patients, but no injuries or illnesses have been reported.
Plain-English summary
Baxter Healthcare Corporation is recalling 49,344 units of Vented Spike Adapter Product Code 2C0471. These sterile, nonpyrogenic IV transfer devices are used to transfer fluids in pharmacy compounding systems. The recall is being conducted because of potential tears in the pouch of the device.
The affected lots were distributed nationwide. The specific lot codes involved in this recall are R13D09024, R13D09107, R13D12101, R13D17068, R13D18066, and R13D20070. The devices were manufactured by an affiliate of Baxter Healthcare Corporation, Clintec Nutrition Division, in Deerfield, Illinois.
Healthcare facilities and pharmacies should check their inventory for these specific lot codes and stop using the affected products. Users should contact Baxter Healthcare for further instructions on how to return or dispose of the recalled items.
The recalled product
- Product
- Vented Spike Adapter Product Code 2C0471, Sterile, nopyrogenic. Manufactured by an affiliate of Baxter Healthcare Corporation, Clintec Nutrition Division, Deerfield IL 60015 USA. An IV transfer device, used to transfer fluids in pharmacy compounding system.
- Manufacturer
- Baxter Healthcare Corp.
- Affected units
- 49,344
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 (6)
- R13D09024
- R13D09107
- R13D12101
- R13D17068
- R13D18066
- R13D20070
Distribution
Distributed nationwide across the United States.
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