FDA Medical Device Recalls (openFDA)
Stryker Instruments Div. of Stryker Corporation: Stryker 100 mL AutoFuser PainPump, single site continuous with bolus, 2 mL/hr, 1 mL bolus, 60 minute bolus refill, 1 x 2.5 in. catheter, sterile, REF 0531-216-025.
- Recall number
- Z-1831-2009
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation
- Product
- Stryker 100 mL AutoFuser PainPump, single site continuous with bolus, 2 mL/hr, 1 mL bolus, 60 minute bolus refill, 1 x 2.5 in. catheter, sterile, REF 0531-216-025.
- Status
- Terminated
- Initiated
- 2009-05-14
- Posted
- 2009-09-04
- Terminated
- 2010-01-20
- Reason
- 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
- 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
- 28,755 of all pumps
- Distribution
- Nationwide and Canada.
- Lot, serial or model codes
- Lots 08137753299 through 09125931326.
- 510(k) numbers
- K041585, K060258
- PMA numbers
- not on file
- Product code
- MEB
- 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
- 3e6df46828c1
- Size
- 288213574 bytes
- Published
- 2026-10-06
- Read
- 2026-10-07T03:20:25.099Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-14
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 3e6df46828c1, published 2026-10-06