FIRMap 60mm Catheter; Size: 60 mm; Length 50.4 inches French Size Diameter: 8.5F (2.84mm) Model number : USAR064060 Ster
FDA device recall Z-2478-2015 · posted 2015-08-28 · Terminated
Recall details
- Recalling firm
- Abbott Electrophysiology
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- MTD
- Quantity affected
- 86 units
- Distribution
- 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.
- Date initiated
- 2015-08-12
- Date posted
- 2015-08-28
- Date terminated
- 2015-09-23
- Location
- Menlo Park, CA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FIRMAP CATHETER (K130827) | Topera, Inc. | 2013-10-31 |