B. Braun Blistered Omnifix L.L. Syringe packaged in the Easypump LT 60-24, 60 ml x 2 ml/hr
FDA Recall Z-2250-2009 · Posted 2009-09-24
Advertisement
Recalling FirmI-Flow Corporation
Recall StatusTerminated
Product CodeFMF
Date Initiated2008-08-01
Date Terminated2009-10-07
Product Quantity1,608 units
Reason for Recall
I-Flow identified a B. Braun syringe package that had a tear/hole in the paper portion of the primary package.
Used to provide an optional filling device for the Easypump.
Firm Action
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.
Root Cause
Packaging process control
Distribution Pattern
France
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement