Abbott FIRMap Catheter Recalled for Incorrect Product Labeling
Abbott is recalling 40 units of FIRMap® Catheter, 60mm Basket due to incorrect product labeling. The recall affects devices distributed in Missouri, California, Ohio, Washington and internationally in Italy and Netherlands.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a FDA Class II medical device recall with incorrect product labeling. No illnesses, injuries, or deaths have been reported. Per the severity rubric, minor labeling errors without reported harm are classified as Moderate (score 2).
Plain-English summary
Abbott is recalling 40 units of FIRMap® Catheter, 60mm Basket (Model Number AR064060) due to incorrect product labeling.
The affected devices were distributed to medical facilities in Missouri, California, Ohio, and Washington, as well as internationally in Italy and the Netherlands. Six batch numbers are affected, with expiration dates ranging from September 2022 to March 2023.
Healthcare facilities should verify their inventory against the affected batch numbers and stop using recalled units. Contact Abbott for guidance regarding this recall.
The recalled product
- Product
- FIRMap" Catheter, 60mm Basket
- Manufacturer
- Abbott
- Category
- Medical Device — Catheter
- Hazard
- Affected units
- 40
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 (8)
- Model Number: AR064060
- UDI Number: ( 01) 0 0810591 02002 4 ( 17) 020531 ( 00) 1 2345678 95
- Batch Numbers: 2158303 (Exp. Date: 30 NOV 2022)
- 2159876 (Exp. Date: 31 JAN 2023)
- 2156510 (Exp. Date: 30 SEP 2022)
- 2162996 (Exp. Date: 31 MAR 2023)
- 2159875 (Exp. Date: 30 NOV 2022)
- and 2159877 ( Exp. Date: 30 NOV 2022).
Distribution
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