8F Safe Sheath Introducer, Catalog number: V18; AngioDynamics, INC. The Valved Introducer sheath is utilized to surgical
FDA device recall Z-0055-2012 · posted 2011-10-13 · Terminated
Recall details
- Recalling firm
- Angiodynamics, INC
- Reason for recall
- The product may contain an incorrect size catheter and introducer.
- Action taken
- AngioDynamics, Inc contacted affected customers initially via telephone and a follow up "Notification of Medical Device Correction" letter was sent dated August 1, 2011. The letter informed them of the problem and provided instructions. Customers were instructed to utilize the 8F Introducer Sheath provided within the 8F Smart Port CT Implantable Port during port implantation. The 8F Valved Sheath (V18) may continue to be utilized during the placement of the 7.5F Smart Port Implantable Port (for example: CT75STSD; CT75STSD-NF). For question on this recall contact AngioDynamics, Inc at (800) 772-6446.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- DYB
- Quantity affected
- 1095 total units
- Distribution
- (USA) Nationwide distribution including the states of CA, FL, GA, IA, IL, IN, KY, MD, MI, MO, NC, NE, NJ, NY, OH, OK, OR, TN, UT, WA and WI.
- Date initiated
- 2011-08-01
- Date posted
- 2011-10-13
- Date terminated
- 2012-03-07
- Location
- Manchester, GA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INTRODUCER SETS, MODELS ADELANTE AND ADELANTE-S (K073100) | Oscor, Inc. | 2007-11-30 |