Recalls / —

—#31483

Product

Millex HA Syringe Filter 0.45um, Sterile Catalog Number: SLHA033SS

FDA product code

FPB — Filter, Infusion Line

Device class

Class 2

Medical specialty

General Hospital

Affected lot / code info

Lot Numbers: F2KN69893 F2MN78131 F2NN82062 F2PN78264 R3DN04757 R3DN04758 R3HN06273 R3HN06274 R3HN89112 R3HN89113 R3HN93120 R3JN17305 R3JN25568 R3JN93121 R3KN94945 R3MN58189

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 #31483. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.