Z-1407-04

Jackson-Pratt Reservoir, 400 mL suction reservoir; a sterile, single use only, Rx device used as a component...

Name: Z-1407-04 Jackson-Pratt Reservoir, 400 mL suction reservoir; a sterile, single use only, Rx device used as a component...
Creator: Cardinal Health
Published: 2004-07-28
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2004-07-28 / Terminated / root cause: labeling and UDI

FDA source

Cardinal Health began a recall of Jackson-Pratt Reservoir, 400 mL suction reservoir; a sterile, single use only, Rx device used as a component of the wound drain system, individually packaged... on 2004-07-28. The reason FDA records is "The products labeled as sterile are not sterile". 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-1407-04
Status: Terminated
Initiated: 2004-07-28
Posted: 2004-08-25
Terminated: 2005-02-10
Recalling firm: Medtronic, Inc.
Product: Jackson-Pratt Reservoir, 400 mL suction reservoir; a sterile, single use only, Rx device used as a component of the wound drain system, individually packaged, 10 reservoirs per case; catalog #SU130-1000; Allegiance Healthcare Corporation, McGaw Park, IL 60085 USA
Product code: GBX Catheter, Irrigation
Reason for recall: The products labeled as sterile are not sterile.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: The accounts were telephoned on 7/28/04 and sent follow-up letters on the same date. They were informed that affected lots of products were not sterile, and were requested to inspect their inventory and segregate the product for return to Cardinal Health. The accounts were instructed to call 800-635-6021 for product return and instructions on how to obtain credit and replacement product.
Quantity in commerce: 60 cases
Distribution: Florida, Arizona, New Jersey and Canada
Product codes and lots: catalog #SU130-1000, lots 1040877, 1040879, 1040991, 1040992

Product code GBX

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)