Recall Z-2249-2009
I-Flow Corporation · initiated August 1, 2008
Product
B. Braun Blistered Omnifix L.L. Syringe packaged in the Easypump LT 100-48, 100 ml x 2 ml/hr Used to provide an optional filling device for the Easypump.
Codes / lots: Lot Number: 7B2775
Reason for recall
I-Flow identified a B. Braun syringe package that had a tear/hole in the paper portion of the primary package.
FDA-determined 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.
Details
- Recall number
- Z-2249-2009
- Initiated
- August 1, 2008
- Posted by FDA
- September 24, 2009
- Terminated
- October 7, 2009
- Product code
- FMF – Syringe, Piston
- Quantity
- 569 units
- Distribution
- France
- Recalling firm
- I-Flow Corporation, Lake Forest, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2250-2009 | B. Braun Blistered Omnifix L.L. Syringe packaged in the Easypump LT 60-24, 60 ml x 2 ml/hrI-Flow identified a B. Braun syringe package that had a tear/hole in the paper portion of the primary… | 08/01/2008Terminated |