B. Braun Blistered Omnifix L.L. Syringe 의 리콜

Recall

53080

Class 2

Z-2249-2009

2008-08-01

2009-09-24

Terminated

United States

2009-10-07

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84711

I-flow identified a b. braun syringe package that had a tear/hole in the paper portion of the primary package.

I-Flow sent a recall letter dated August 1, 2008 to consignees telling them of the above mentioned recall and asking them to Inspect their Easypump inventory to determine if they have any of the affected lots identified on this Recall Notification Letter. They were told not to distribute affected devices and quarantined remaining inventory immediately. They were asked to check the appropriate response on the attached I-Flow Fax sheet and return the form back to I-Flow within 48 hours of receipt. The I-Flow Customer Service number (949) 206-2700, and hours of operation (7:00 am - 5:00 pm PST) were provided to answer questions.