Z-0152-04

100 inch (254 cm) 15 Drop Administration Set with FlowSafe Flow Controller and Max Y Connector, 50 per box...

Name: Z-0152-04 100 inch (254 cm) 15 Drop Administration Set with FlowSafe Flow Controller and Max Y Connector, 50 per box...
Creator: Maximus Medical Products Inc
Published: 2003-10-30
License: https://open.fda.gov/license/

Maximus Medical Products Inc / initiated 2003-10-30 / Terminated / root cause: labeling and UDI

FDA source

Maximus Medical Products Inc began a recall of 100 inch (254 cm) 15 Drop Administration Set with FlowSafe Flow Controller and Max Y Connector, 50 per box. Product No. MFS102 on 2003-10-30. The reason FDA records is "Mislabeled with wrong drop size drip chamber specification". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0152-04
Status: Terminated
Initiated: 2003-10-30
Posted: 2004-07-20
Terminated: 2003-11-25
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
Product code: FPA Set, Administration, Intravascular
Reason for recall: Mislabeled with wrong drop size drip chamber specification.
Root cause tag: labeling and UDI
FDA 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 in commerce: 63 cases, 50 per case.
Distribution: CO, PA,
Product codes and lots: Lots D316302 and D323912.

Product code FPA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)