Abbott Medical Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303
Brand
Abbott Medical
Lot Codes / Batch Numbers
UDI: (01)15414734203903(17)220731(10)7133555, Batch: 7133555
Products Sold
UDI: (01)15414734203903(17)220731(10)7133555, Batch: 7133555
Abbott Medical is recalling Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303 due to Fast-Cath Trio Hemostasis Introducer devices contained 12F sized dilators and sheaths instead of the expected 14F devices.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Fast-Cath Trio Hemostasis Introducer devices contained 12F sized dilators and sheaths instead of the expected 14F devices.
Recommended Action
Per FDA guidance
Beginning on 12/09/2019, consignees were notified in person by an Abbott field representative. The firm is seeking return of the affected units. For questions about this issue or for replenishment contact your local Abbott Representative or Abbott Support at 1-855-478-5833 (option 1).
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026