Z-1853-2009

Stryker 550 mL AutoFuser PainPump, dual site continuous, 4 mL/hr, 2 x 10.0 in. catheters, sterile, REF...

Name: Z-1853-2009 Stryker 550 mL AutoFuser PainPump, dual site continuous, 4 mL/hr, 2 x 10.0 in. catheters, sterile, REF...
Creator: Stryker Instruments Div. of Stryker Corporation
Published: 2009-05-14
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2009-05-14 / Terminated / root cause: manufacturing process

FDA source

Stryker Instruments Div. of Stryker Corporation began a recall of Stryker 550 mL AutoFuser PainPump, dual site continuous, 4 mL/hr, 2 x 10.0 in. catheters, sterile, REF 0535-400-210 on 2009-05-14. The reason FDA records is "Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1853-2009
Status: Terminated
Initiated: 2009-05-14
Posted: 2009-09-04
Terminated: 2010-01-20
Recalling firm: Stryker Corp.
Product: Stryker 550 mL AutoFuser PainPump, dual site continuous, 4 mL/hr, 2 x 10.0 in. catheters, sterile, REF 0535-400-210.
Product code: MEB Pump, Infusion, Elastomeric
Reason for recall: Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Stryker sent all consignees a Medical Device Recall Notification letter dated 5/14/09 and instructed to locate and destroy the recalled products and to complete and return the business reply card.
Quantity in commerce: 28,755 of all pumps
Distribution: Nationwide and Canada.
Product codes and lots: Lots 08142756254 through 09125933719.

Product code MEB

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)