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 identify using conventional mapping systems alone.
FDA Recall Z-2478-2015 · Posted 2015-08-28
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Recalling FirmAbbott Electrophysiology
Recall StatusTerminated
Product CodeMTD
Date Initiated2015-08-12
Date Terminated2015-09-23
Product Quantity86 units
Reason for Recall
The expiration date was incorrectly printed on the pouch/box labels of 19 products that were shipped to customer sites. The manufacturing date was accidentally used (copied) for the expiration date.
Firm Action
The firm, Abbott Electrophysiology, sent an "URGENT PRODUCT RECALL" letter dated August 11, 2015. A customer recall notification letter was distributed to firm representatives who will visit each consignee and inspect inventory for affected product. Letters were provided to reps on August 12, 2015. The letter describes the product, problem and actions to be taken. The customers were informed that the product they have in stock will be return to the firm and will be provided a replacement product free of charge.
If you have any questions, contact Quality Director at 650-681-1744.
Root Cause
Incorrect or no expiration date
Distribution Pattern
US Distribution in states of: KY, IN, MO, NY, OH, TX, LA, IL, PA, NJ, WA, VA, FL, GA, CT, CA, AZ, CO, and TN.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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