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Class 2 Device Recall Millipore |
 |
| Date Initiated by Firm |
January 26, 2004 |
| Date Posted |
July 20, 2004 |
| Recall Status1 |
Terminated 3 on June 11, 2015 |
| Recall Number |
Z-0574-04 |
| Recall Event ID |
28223 |
| Product Classification |
Filter, Infusion Line - Product Code FPB
|
| Product |
Millex-HA Syringe Driven Filter Unit, 0.45 um, Sterile
Catalog Number: SLHAM33SS |
| Code Information |
Lot number: F2PN86705 |
Recalling Firm/
Manufacturer |
Millipore Corp.
80 Ashby Rd
Bedford MA 01730-2237
|
| For Additional Information Contact |
Thomas Borrows
781-533-2622
|
Manufacturer Reason
for Recall |
Lack of assurance of sterility
|
FDA Determined
Cause 2 |
Other |
| Action |
Millipore notified direct and distributor accounts by Certified letter on 1/26/04. Users are requested to return product. Millipore France and Ireland coordinating recall to the international accounts. |
| Quantity in Commerce |
11 boxes ( 50/box) |
| Distribution |
CA, CO, DE, IL, OH, PA, MA, MO, MD, MT, RI, VA
Canada |
| 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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