Abbott FIRMap 60mm Catheter Recalled for Incorrect Expiration Date Labeling
Abbott Electrophysiology is recalling 86 units of FIRMap 60mm Catheters because the expiration date was incorrectly printed on the labels.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a documentation/labeling error.
Plain-English summary
Abbott Electrophysiology is recalling 86 units of the FIRMap 60mm Catheter, model number USAR064060. The recall involves a specific lot (TPR031615-01) of these sterile, prescription-only cardiovascular catheters used in cardiac electrophysiology procedures.
The recall was initiated because the expiration date was incorrectly printed on the pouch and box labels of 19 products that were shipped to customer sites. The manufacturing date was accidentally used in place of the expiration date. The affected units were distributed in the United States to the states of Kentucky, Indiana, Missouri, New York, Ohio, Texas, Louisiana, Illinois, Pennsylvania, New Jersey, Washington, Virginia, Florida, Georgia, Connecticut, California, Arizona, Colorado, and Tennessee.
Healthcare facilities and customers who have received these specific units should stop using them and contact Abbott Electrophysiology for further instructions. This recall is classified as Class III by the FDA, indicating that the use of or exposure to the product is not likely to cause adverse health consequences.
The recalled product
- Product
- FIRMap 60mm Catheter; Size: 60 mm; Length 50.4 inches French Size Diameter: 8.5F (2.84mm) Model number : USAR064060 Sterile, Rx only Cardiovascular: For use in cardiac electrophysiology procedures to assist in the diagnosis of complex arrhythmias that may be difficult to
- Manufacturer
- Abbott Electrophysiology
- Hazard
- Affected units
- 86
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 (2)
- Model number : USAR064060
- Lot code: TPR031615-01
Distribution
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