Recalls / —

—#31405

Product

Millex-HA Syringe Driven Filter Unit, 0.45 um, Sterile Catalog Number: SLHAM33SS

FDA product code

FPB — Filter, Infusion Line

Device class

Class 2

Medical specialty

General Hospital

Affected lot / code info

Lot number: F2PN86705

Why it was recalled

Lack of assurance of sterility

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm

Millipore Corp.

Address

80 Ashby Rd, Bedford, Massachusetts 01730-2237

Distribution

Distribution pattern

CA, CO, DE, IL, OH, PA, MA, MO, MD, MT, RI, VA Canada

Timeline

Recall initiated

2004-01-26

Posted by FDA

2004-07-20

Terminated

2015-06-11

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #31405. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.