Stryker Instruments Div. of Stryker Corporation Stryker 550 mL AutoFuser PainPump, single site continuous, 10 mL/hr, sterile, REF 0535-100-000. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Stryker 550 mL AutoFuser PainPump, single site continuous, 10 mL/hr, sterile, REF 0535-100-000.
Brand
Stryker Instruments Div. of Stryker Corporation
Lot Codes / Batch Numbers
Lots 08136753321 through 09125932990.
Products Sold
Lots 08136753321 through 09125932990.
Stryker Instruments Div. of Stryker Corporation is recalling Stryker 550 mL AutoFuser PainPump, single site continuous, 10 mL/hr, sterile, REF 0535-100-000. due to Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026