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FDA Medical Device Recalls (openFDA)

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

Recall number
Z-0577-04
Recalling firm
Millipore Corp.
Product
Millex HA Syringe Filter 0.45um, Sterile Catalog Number: SLHA033SS
Status
Terminated
Initiated
2004-01-26
Posted
2004-07-20
Terminated
2015-06-11
Reason
Lack of assurance of sterility
Root cause
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
15 boxes ( 50/box)
Distribution
CA, CO, DE, IL, OH, PA, MA, MO, MD, MT, RI, VA Canada
Lot, serial or model codes
Lot Numbers: F2KN69893 F2MN78131 F2NN82062 F2PN78264 R3DN04757 R3DN04758 R3HN06273 R3HN06274 R3HN89112 R3HN89113 R3HN93120 R3JN17305 R3JN25568 R3JN93121 R3KN94945 R3MN58189
510(k) numbers
not on file
PMA numbers
not on file
Product code
FPB
Firm FEI
1216103
Firm city
Bedford
Firm state
MA
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

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Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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