Ultimum Hemostasis Introducer devices recalled due to manufacturing error
Abbott is recalling one lot of Ultimum Hemostasis Introducer devices due to a manufacturing error that resulted in incorrect hub and length. Affected devices are 12 cm long instead of the intended 5 cm.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a medical device with a functional manufacturing defect that could affect patient safety. No injuries, illnesses, or deaths have been reported, placing it in the High severity category per the rubric for risk-of-harm products without reported harm.
Plain-English summary
Abbott is recalling Ultimum Hemostasis Introducer 5f 1.67 MM devices manufactured in lot 7748246 due to a manufacturing error. The devices were produced with an incorrect hub and overall length of 12 centimeters instead of the intended 5 centimeters.
Hemostasis introducers are vascular access devices used in medical procedures. A device with incorrect dimensions could potentially affect proper insertion, placement, or hemostasis control during use.
The recall affects one lot consisting of 10 units. Distribution included locations worldwide, with specific distribution in Missouri and Australia.
Patients or healthcare providers who have received or used devices from this recall lot should contact Abbott for further instructions. No injuries or illnesses have been reported to date.
The recalled product
- Product
- Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM
- Manufacturer
- Abbott
- Category
- Medical Device — Vascular Access
- Affected units
- 10
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 (3)
- Model 407831
- Lot 7748246
- GTIN: 15414734008805
Distribution
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