Recalls / —

—#31481

Product

Millex GS- Syringe Filter 0.22um, Sterile Catalog Number: SLGS033SS

FDA product code

FPB — Filter, Infusion Line

Device class

Class 2

Medical specialty

General Hospital

Affected lot / code info

Lot Numbers: F2JN63560 F2KN78263 F2MN78127 F2NN78129 F2NN86699 F2PN69885 R3AN96873 R3AN96873Q R3AN97497 R3AN97497Q R3DN04753 R3DN04754 R3HN06269 R3HN06271 R3HN06272 R3HN89115 R3HN89117 R3JN94935 R3JN94936 R3JN94938 R3JN94940

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 #31481. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.