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FDA Medical Device Recalls (openFDA)

Maximus Medical Products Inc: 100 inch (254 cm) 15 Drop Administration Set with FlowSafe Flow Controller and Max Y Connector, 50 per box. Product No. MFS102

Recall number
Z-0152-04
Recalling firm
Maximus Medical Products Inc
Product
100 inch (254 cm) 15 Drop Administration Set with FlowSafe Flow Controller and Max Y Connector, 50 per box. Product No. MFS102
Status
Terminated
Initiated
2003-10-30
Posted
2004-07-20
Terminated
2003-11-25
Reason
Mislabeled with wrong drop size drip chamber specification.
Root cause
Other
Action
The firm called and sent fax recall letters on or about 10/30/2003. Labels were shipped and applied to stock in question. Recall is complete.
Quantity
63 cases, 50 per case.
Distribution
CO, PA,
Lot, serial or model codes
Lots D316302 and D323912.
510(k) numbers
not on file
PMA numbers
not on file
Product code
FPA
Firm FEI
3003698179
Firm city
Costa Mesa
Firm state
CA
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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