LifePort, AngioDynamics, Inc., One Horizon Way, Manchester, GA 31816.
FDA device recall Z-0405-2011 · posted 2010-11-17 · Terminated
Recall details
- Recalling firm
- Angiodynamics, INC
- Reason for recall
- Labeling Error; The labeling for the specific products incorrectly identified that the packaged device kit contains a Lifeguard Safety Infusion Set.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- see product one.
- Distribution
- Nationwide Distribution : Throughout the US.
- Date initiated
- 2010-09-27
- Date posted
- 2010-11-17
- Date terminated
- 2011-06-21
- Location
- Manchester, GA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LIFEPORT ATTACHABLE SYSTEM W/INDUCER KIT LPS 5555 (K915273) | Strato Medical Corp. | 1993-07-07 |
| STRATO PORT INTRODUCER KT(10 FR) LPS 5013/MODIFIED (K905839) | Strato Medical Corp. | 1991-04-19 |
| STRATO PORT INTRODUCER KT(10 FR) LPS 5057/MODIFIED (K905840) | Strato Medical Corp. | 1991-04-19 |
| STRATO PORT INTRODUCER KT(9 FR) LPS 5513/MODIFIED (K905845) | Strato Medical Corp. | 1991-04-19 |
| LIFEPORT VASCU ACCESS SYST/PORT INTRO KIT 7015 (K911355) | Strato Medical Corp. | 1991-04-15 |