FDA Medical Device Recalls (openFDA)
Stryker Instruments Div. of Stryker Corporation: Stryker 275 mL AutoFuser PainPump, dual site continuous, 4 mL/hr, 2 x 5.0 in. catheters, sterile, REF 0532-400-250.
- Recall number
- Z-1843-2009
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation
- Product
- Stryker 275 mL AutoFuser PainPump, dual site continuous, 4 mL/hr, 2 x 5.0 in. catheters, sterile, REF 0532-400-250.
- 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 08136753311 through 09121931323.
- 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
- 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
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 b87518bfe2e8, published 2026-09-28