Reported Jan 5, 2022 · Terminated
Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM
Abbott
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Abbott · 5050 Nathan Ln N · Plymouth, MN · 55442-3209
Is this the product you have?
- Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM
- Lot codes and dates
Model 407831Lot 7748246
- GTIN15414734008805
- Amount recalled
- 10 units
Where it was sold
- Nationwide
- MO
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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