FDA Medical Device Recalls (openFDA)
Stryker Instruments Div. of Stryker Corporation: Stryker PainPump2 250 mL Painpump with Luer Lock Tubing Set, REF 525-350, Sterile, Rx only, Stryker Instruments, Kalamazoo, MI.
- Recall number
- Z-0096-2011
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation
- Product
- Stryker PainPump2 250 mL Painpump with Luer Lock Tubing Set, REF 525-350, Sterile, Rx only, Stryker Instruments, Kalamazoo, MI.
- Status
- Terminated
- Initiated
- 2010-08-16
- Posted
- 2010-10-20
- Terminated
- 2011-04-21
- Reason
- The instructions for use (IFU) has been revised for health care professionals. The indication for use has been changed to remove site specific pain management. The firm has revised the warning to not use the pump around joint spaces. A warning has been added regarding the use of the pump with anticoagulants in epidural applications. A special reminder to users to always evaluate the potential
- Root cause
- Other
- Action
- Stryker Instruments sent Urgent Medical Device Recall Notification letters dated 8/16/2010 to healthcare professionals. The recall letters outlined the changes for the instructions for the use of these products. The letters informed the healthcare professional to review the new IFU, to distribute the new IFU to all healthcare professionals that use the device, and to complete and return the business reply form. The letters included a complete IFU that was to be used with any remaining stock of devices. Customers should dispose of the old version of the IFU. There is no product being returned for this recall.
- Quantity
- 11,976 all products
- Distribution
- US, Canada and Australia.
- Lot, serial or model codes
- '09160012, '09163012, '09176012, '09197012, '09198012, '09203012, '09211012, '09213022, '09217012, '09222012, '09230012, '09234012, '09241012, '09246012, '09258012, '09262012, '09283012, '09289012, '09290012, '09292022, '10012012, '10013012, '10014012, '10015012, '10018022, '10019012, '10021012, '10028012, '10029012, '10032022, '10033012, and '10039022.
- 510(k) numbers
- ["K042405","K043466"]
- PMA numbers
- not on file
- Product code
- FRN
- Firm FEI
- 1811755
- Firm city
- Kalamazoo
- Firm state
- MI
- 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