Home › Device types › FFA
Tube, Drainage, Suprapubic
FDA product code FFA · Class 2 · Gastroenterology, Urology
79
Registered devices
677
Adverse events
10
Recalls
3
510(k) clearances
Devices with this code
Flexima™ APDL — BOSTON SCIENTIFIC CORPORATIONStretch™ VL — BOSTON SCIENTIFIC CORPORATIONvanSonnenberg™ Sump — BOSTON SCIENTIFIC CORPORATIONFlexima™ APD™ — BOSTON SCIENTIFIC CORPORATIONUro-Kit® Reusable Latex Leg Bag System 9 oz. — UROCARE PRODUCTS, INC.TAUT — TELEFLEX INCORPORATEDvanSonnenberg™ Sump — BOSTON SCIENTIFIC CORPORATIONTAUT — TELEFLEX INCORPORATEDTAUT — TELEFLEX INCORPORATEDStretch™ VL — BOSTON SCIENTIFIC CORPORATIONFlexima™ APD™ — BOSTON SCIENTIFIC CORPORATIONTAUT — TELEFLEX INCORPORATEDFlexima™ APDL — BOSTON SCIENTIFIC CORPORATIONFlexima™ APD™ — BOSTON SCIENTIFIC CORPORATIONUro-Kit® Reusable Latex Leg Bag System 26 oz. — UROCARE PRODUCTS, INC.Stretch™ VL — BOSTON SCIENTIFIC CORPORATIONStretch™ VL — BOSTON SCIENTIFIC CORPORATIONUro-Kit® Reusable Latex Leg Bag System 26 oz. — UROCARE PRODUCTS, INC.vanSonnenberg™ Sump — BOSTON SCIENTIFIC CORPORATIONTAUT — TELEFLEX INCORPORATEDFlexima™ APD™ — BOSTON SCIENTIFIC CORPORATIONFlexima™ APDL — BOSTON SCIENTIFIC CORPORATIONFlexima™ APDL — BOSTON SCIENTIFIC CORPORATIONFlexima™ APD™ — BOSTON SCIENTIFIC CORPORATION
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-07-18 | Boston Scientific Corporation | There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility. |
| 2024-07-18 | Boston Scientific Corporation | There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility. |
| 2024-07-18 | Boston Scientific Corporation | There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility. |
| 2024-07-18 | Boston Scientific Corporation | There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility. |
| 2024-07-18 | Boston Scientific Corporation | There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility. |
| 2009-03-18 | Boston Scientific Corporation | Boston Scientific Corporation is initiating an urgent Field Correction related to its Flexima and Percuflex Drainage Catheter Family (Pigtail Style). During t |
| 2009-03-18 | Boston Scientific Corporation | Boston Scientific Corporation is initiating an urgent Field Correction related to its Flexima and Percuflex Drainage Catheter Family (Pigtail Style). During t |
| 2009-03-18 | Boston Scientific Corporation | Boston Scientific Corporation is initiating an urgent Field Correction related to its Flexima and Percuflex Drainage Catheter Family (Pigtail Style). During t |
| 2009-03-18 | Boston Scientific Corporation | Boston Scientific Corporation is initiating an urgent Field Correction related to its Flexima and Percuflex Drainage Catheter Family (Pigtail Style). During t |
| 2006-09-21 | Boston Scientific Corp | Sterility compromised/package integrity : the bottom of the Tyvek pouch may not have been sealed. |
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