B. Braun Blistered Omnifix L.L. Syringe packaged in the Easypump LT 60-24, 60 ml x 2 ml/hr
This recall has been terminated (originally issued September 24, 2009).
- Company
- I-Flow Corporation
- Recall Initiated
- August 1, 2008
- Posted
- September 24, 2009
- Terminated
- October 7, 2009
- Recall Number
- Z-2250-2009
- Quantity
- 1,608 units
- Firm Location
- Lake Forest, CA
- Official Source
- View on FDA website ↗
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.
Distribution
France
Lot / Code Info
Lot Numers: 7B2868, 812193, 832357
Root Cause
Packaging process control
Action Taken
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.