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Terminated

LifePort, AngioDynamics, Inc., One Horizon Way, Manchester, GA 31816.

FDA Recall Z-0405-2011 · Posted 2010-11-17

Recalling FirmAngiodynamics, INC
Recall StatusTerminated
Product CodeFRN
Date Initiated2010-09-27
Date Terminated2011-06-21
Product Quantitysee product one.

Reason for Recall

Labeling Error; The labeling for the specific products incorrectly identified that the packaged device kit contains a Lifeguard Safety Infusion Set.

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide Distribution : Throughout the US.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K915273LIFEPORT ATTACHABLE SYSTEM W/INDUCER KIT LPS 5555Strato Medical Corp. · 1993-07-07K905839STRATO PORT INTRODUCER KT(10 FR) LPS 5013/MODIFIEDStrato Medical Corp. · 1991-04-19K905840STRATO PORT INTRODUCER KT(10 FR) LPS 5057/MODIFIEDStrato Medical Corp. · 1991-04-19K905845STRATO PORT INTRODUCER KT(9 FR) LPS 5513/MODIFIEDStrato Medical Corp. · 1991-04-19K911355LIFEPORT VASCU ACCESS SYST/PORT INTRO KIT 7015Strato Medical Corp. · 1991-04-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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