Recall Z-0405-2011 ยท FRN Pump, Infusion
Angiodynamics, INC
LifePort, AngioDynamics, Inc., One Horizon Way, Manchester, GA 31816.
| Date | Nov 17, 2010 (initiated Sep 27, 2010) |
| Status | Terminated |
| Reason | Labeling Error; The labeling for the specific products incorrectly identified that the packaged device kit contains a Lifeguard Safety Infusion Set. |
| Root cause | Other |
| Action | AngioDynamics issued a Notification of Medical Device Correction letter dated September 27, 2010 to customers. The notification served to make the customer aware of the mislabeling. Customers were instructed not to return the affected products. Customers can contact AngioDynamics at 1 800 772-6446 about this correction. |
| Quantity | see product one. |
| Distribution | Nationwide Distribution : Throughout the US. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K905839 | STRATO PORT INTRODUCER KT(10 FR) LPS 5013/MODIFIED Strato Medical Corp., Apr 19, 1991 |
| K905840 | STRATO PORT INTRODUCER KT(10 FR) LPS 5057/MODIFIED Strato Medical Corp., Apr 19, 1991 |
| K905845 | STRATO PORT INTRODUCER KT(9 FR) LPS 5513/MODIFIED Strato Medical Corp., Apr 19, 1991 |
| K911355 | LIFEPORT VASCU ACCESS SYST/PORT INTRO KIT 7015 Strato Medical Corp., Apr 15, 1991 |
| K915273 | LIFEPORT ATTACHABLE SYSTEM W/INDUCER KIT LPS 5555 Strato Medical Corp., Jul 7, 1993 |