Baxter Recalls VIAL-MATE Adaptors Due to Incomplete Foil Seal
Baxter Healthcare is recalling 38,400 units of VIAL-MATE Adaptors because an incomplete foil seal may 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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Baxter Healthcare Corporation is recalling 38,400 units of the VIAL-MATE Adaptor, catalog number 2B8071. The device is a sterile reconstitution tool labeled for use with 20 mm drug vials and 50mL, 100mL, and 250mL Single Pack Mini Bags. The recall is limited to Lot Number GR13G23028.
The recall was initiated because an incomplete foil seal was identified on one lot of the sterile product. This defect may compromise the sterile barrier of the device. The affected units were distributed nationwide, including in West Virginia, Kentucky, Iowa, Arkansas, Ohio, Illinois, Indiana, Michigan, Kansas, Tennessee, Wisconsin, Minnesota, and Missouri.
Healthcare providers and facilities should stop using the affected VIAL-MATE Adaptors and contact Baxter Healthcare for instructions on return or replacement. Patients should consult their healthcare provider if they have questions regarding the use of this device.
The recalled product
- Product
- Baxter, VIAL-MATE Adaptor, 2B8071, Rx Only, STERILE R, Baxter Healthcare Corporation, Deerfield, IL 30015 USA The VIAL-MATE is reconstitution device labeled for use with 20 mm drug vials and 50mL, 100mL, and 250mL Single Pack Mini Bags.
- Manufacturer
- Baxter Healthcare Corp.
- Hazard
- Affected units
- 38,400
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)
- Lot Number GR13G23028
Distribution
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