Baxa Vial Adapter Recall for Incorrect Expiry Date
Baxter Healthcare is voluntarily recalling one lot of Baxa Vial Adapters due to an incorrect expiry date.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is due to a documentation issue (incorrect expiry date) with no reported injuries or illnesses, fitting the criteria for a Low severity recall.
Plain-English summary
Baxter Healthcare Corporation is voluntarily recalling one lot of Baxa Vial Adapters, 14mm - Luer Lock. The recall is being conducted because the product has an incorrect expiry date.
The affected product is identified by Lot or Serial No. 785518. The recall involves 34 cases of the single-use needleless access device, which is used for reconstitution and drug transfer.
The product was distributed to one customer in North Carolina. Consumers and healthcare providers should stop using the affected units and contact the manufacturer for further instructions.
The recalled product
- Product
- Baxa Vial Adapter, 14mm - Luer Lock, Order No. REF: 90, Quantity: 50 each, Single Use. Product Code H93890. Used as a needleless access device for reconstitution and drug transfer.
- Manufacturer
- Baxa Corporation
- Category
- Medical Device — Vial Adapter
- Hazard
- Affected units
- 34
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 or Serial No. 785518
Distribution
Distributed in 1 state:
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