Recalls / —
—#103021
Product
8F Safe Sheath Introducer, Catalog number: V18; AngioDynamics, INC. The Valved Introducer sheath is utilized to surgically place the catheter during the port implantation procedure.
- FDA product code
- DYB — Introducer, Catheter
- Device class
- Class 2
- Medical specialty
- Cardiovascular
- 510(k) numbers
- K073100
- Affected lot / code info
- Catalog number: V18, Lot numbers D1-01664 and D101799
Why it was recalled
The product may contain an incorrect size catheter and introducer.
Root cause (FDA determination)
Device Design
Action the firm took
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.
Recalling firm
- Firm
- Angiodynamics, INC
- Address
- 1 Horizon Way, Manchester, Georgia 31816-1749
Distribution
- Distribution pattern
- (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.
Timeline
- Recall initiated
- 2011-08-01
- Posted by FDA
- 2011-10-13
- Terminated
- 2012-03-07
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #103021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.