Date Initiated by Firm | August 01, 2008 |
Date Posted | September 24, 2009 |
Recall Status1 |
Terminated 3 on October 07, 2009 |
Recall Number | Z-2249-2009 |
Recall Event ID |
53080 |
510(K)Number | K071459 |
Product Classification |
Piston syringes, Insulin syringes - Product Code FMF
|
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. |
Code Information |
Lot Number: 7B2775 |
Recalling Firm/ Manufacturer |
I-Flow Corporation 20202 Windrow Dr Lake Forest CA 92630-8152
|
For Additional Information Contact | 949-206-2700 |
Manufacturer 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 2 | 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 |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = FMF
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