Ultimum Hemostasis Introducer 5f 1.67 MM recall
Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM
Why was Ultimum Hemostasis Introducer 5f 1.67 MM recalled?
As a result of a manufacturing error, one (1) lot of Ultimum Hemostasis Introducer devices was manufactured with an incorrect hub and overall length. The devices manufactured were 12 cm in length instead of the intended 5 cm in length.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model 407831, Lot 7748246, GTIN: 15414734008805
- Product
- Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM
- Recalling firm
- Abbott
- Quantity
- 10 units
- Distribution
- Worldwide distribution - US Nationwide distribution in the state of Missouri and the country of Australia.
- Recall date
- January 5, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)