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
FDA device recall Z-2249-2009 · posted 2009-09-24 · Terminated
Recall details
- Recalling firm
- I-Flow Corporation
- Reason for recall
- I-Flow identified a B. Braun syringe package that had a tear/hole in the paper portion of the primary package.
- 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.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- FMF
- Quantity affected
- 569 units
- Distribution
- France
- Date initiated
- 2008-08-01
- Date posted
- 2009-09-24
- Date terminated
- 2009-10-07
- Location
- Lake Forest, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| B. BRAUN PISTON SYRINGES AND OMNICAN AND OMNIFIX INSULIN SYRINGES (K071459) | B.Braun Medical, Inc. | 2007-08-16 |