Abbott Vascular Recalls PLUS 30 Priority Pack Accessory Kit Due to Expiration Error
Abbott Vascular is recalling 26 units of the PLUS 30 Priority Pack Accessory Kit because an incorrect expiration date was entered for one lot.
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, but the source text identifies the issue as a documentation error (incorrect expiration date) with no reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Abbott Vascular is recalling 26 units of the PLUS 30 Priority Pack Accessory Kit. The recall is due to an incorrect expiration date being entered for one specific lot of the product.
The PLUS 30 Priority Pack Accessory Kit is recommended for use during vascular procedures in conjunction with interventional and/or diagnostic devices, such as balloon dilatation catheters, atherectomy devices, stent delivery systems, and intravascular ultrasound devices. The affected lot number is 60047593, with Device Identifier 08717648 01360 7 and Part Number 1000185.
The product was distributed nationwide in the United States, specifically in North Carolina and New York. Healthcare facilities and consumers should stop using the affected product and contact Abbott Vascular for further instructions or a replacement.
The recalled product
- Product
- PLUS 30 PRIORITY PACK Accessory Kit Product Usage: Is recommended for use during vascular procedures in conjunction with interventional and / or diagnostic devices (e.g., balloon dilatation catheters, atherectomy devices, stent delivery systems, intravascular ultrasound…
- Manufacturer
- Abbott Vascular
- Hazard
- Affected units
- 26
Distribution
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