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The official notice did not include a photo. Check the product details and identifiers below.
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Introducer kits in impella pump set and axillary insertion kit
Official notice
21 Dec 2023
An official Health Canada notice concerns Introducer kits in impella pump set and axillary insertion kit. There is a potential risk of packaging damage for introducer kits which may compromise the sterile barrier. There have been no reported complaints for this type of damage and this issue was found in <0.6% of all introducer kits that was received. The following introducer kit identifiers, 0052-3006, 0052-3046, 0052-3014, 0052-3025, 0052-3052 which are part of the Impella pump sets and insertion kits are affected by the recall action. Recall Start Date: December 11, 2023 Published 2023-12-21.
What to do now
Contact the manufacturer if you require additional information.
Recall number
74772
Official notice
2023-12-21
The hazard
The hazard
There is a potential risk of packaging damage for introducer kits which may compromise the sterile barrier. There have been no reported complaints for this type of damage and this issue was found in <0.6% of all introducer kits that was received. The following introducer kit identifiers, 0052-3006, 0052-3046, 0052-3014, 0052-3025, 0052-3052 which are part of the Impella pump sets and insertion kits are affected by the recall action. Recall Start Date: December 11, 2023
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
Recall Numbers
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Turn on recall alertsAffected products
Affected products
Product 1
Product 2
Product 3
Product 4
Product 5
Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Manufacturer
Phone
Brand: Abiomed, Introducer Kits In Impella Pump Set And Axillary Insertion Kit.
Source & status
Source & status
Source
Tier
Category
Classification
App estimate
Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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