Abbott Recalls Fast-Cath Hemostasis Introducers Due to Incorrect Size
Abbott Medical is recalling 380 Fast-Cath Hemostasis Introducers because three lots contained 8F components instead of the labeled 8.5F size.
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: The recall involves a medical device with a significant specification error (incorrect size) that poses a risk of harm during use, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Abbott Medical is recalling 380 units of the Fast-Cath Hemostasis Introducer, reference number 406143. The recall involves three specific lots: 6917183, 6950628, and 7099144. These devices are indicated for the introduction of angiographic catheters, closed-end catheters, balloon catheters, and electrodes into a vessel where minimizing blood loss is essential.
The recall was initiated because the three affected lots contained 8F sized dilators and sheaths instead of the expected 8.5F devices. This discrepancy between the actual component size and the labeled size could affect the device's performance during medical procedures.
The affected devices were distributed worldwide, including nationwide distribution in the United States across the states of Massachusetts, Virginia, New Hampshire, Florida, Connecticut, Utah, Ohio, Wisconsin, New York, Iowa, Michigan, Mississippi, and Pennsylvania, as well as in Canada and the Czech Republic. Healthcare providers and facilities should check their inventory for the specific lot numbers listed and stop using the affected devices.
The recalled product
- Product
- Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 - Product Usage: The Fast-Cath Hemostasis Introducers are indicated for the introduction of angiographic catheters, closed-end catheters, balloon catheters, and electrodes into a vessel where…
- Manufacturer
- Abbott Medical
- Affected units
- 380
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 (4)
- Batch 6917183
- UDI (01)15414734014219(17)220228(10)6917183 Batch 6950628
- UDI (01)15414734014219(17)220331(10)6950628 Batch 7099144
- UDI (01)15414734014219(17)220630(10)7099144
Distribution
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