Z-2249-2009

B. Braun Blistered Omnifix L.L. Syringe packaged in the Easypump LT 100-48, 100 ml x 2 ml/hr Used to provide...

Name: Z-2249-2009 B. Braun Blistered Omnifix L.L. Syringe packaged in the Easypump LT 100-48, 100 ml x 2 ml/hr Used to provide...
Creator: I-Flow Corporation
Published: 2008-08-01
License: https://open.fda.gov/license/

Halyard Health / initiated 2008-08-01 / Terminated / root cause: packaging

FDA source

I-Flow Corporation began a recall of 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 on 2008-08-01. The reason FDA records is "I-Flow identified a B. Braun syringe package that had a tear/hole in the paper portion of the primary package". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2249-2009
Status: Terminated
Initiated: 2008-08-01
Posted: 2009-09-24
Terminated: 2009-10-07
Recalling firm: Halyard Health
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.
Product code: FMF Syringe, Piston
Reason for recall: I-Flow identified a B. Braun syringe package that had a tear/hole in the paper portion of the primary package.
Root cause tag: packaging
FDA 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) were provided to answer questions.
Quantity in commerce: 569 units
Distribution: France
Product codes and lots: Lot Number: 7B2775

Product code FMF

K071459Class IIB. Braun Piston Syringes and Omnican and Omnifix Insulin SyringesB.Braun Medical, Inc. / cleared 2007-08-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)