Recall Z-2250-2009 ยท FMF Syringe, Piston
I-Flow Corporation
B. Braun Blistered Omnifix L.L. Syringe packaged in the Easypump LT 60-24, 60 ml x 2 ml/hr
| Date | Sep 24, 2009 (initiated Aug 1, 2008) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Packaging process control |
| 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 |
| Quantity | 1,608 units |
| Distribution | France |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071459 | B. BRAUN PISTON SYRINGES AND OMNICAN AND OMNIFIX INSULIN SYRINGES B.Braun Medical, Inc., Aug 16, 2007 |