FDA Medical Device Recalls (openFDA)
Stryker Instruments Div. of Stryker Corporation: Stryker PainPump2 250 mL PainPump with Luer Lock Tubing Set, sterile, REF 525-350, Stryker Instruments, Kalamazoo, MI. Delivers controlled amounts of medication and narcotics.
- Recall number
- Z-2591-2010
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation
- Product
- Stryker PainPump2 250 mL PainPump with Luer Lock Tubing Set, sterile, REF 525-350, Stryker Instruments, Kalamazoo, MI. Delivers controlled amounts of medication and narcotics.
- Status
- Terminated
- Initiated
- 2010-09-02
- Posted
- 2010-09-28
- Terminated
- 2011-04-21
- Reason
- All of the failures lead to the patient receiving less medication than intended. Certain lots of the pain pump have a high failure rate associated with a cracked port housing which leads to internal or external leaks. Some lots have a high failure rate associated with E2 errors.
- Root cause
- Nonconforming Material/Component
- Action
- The firm sent our Urgent Medical Device Recall Notices dated 7/12/2010 to Risk Managers and Materials Managers. The recall notice listed specific lots of PainPump2 and PainPump2 BlockAid that were under recall. Consignees were told to check stock for the recalled product, quarantine the product, and contact Stryker to arrange return shipment of the recalled product. On 9/2/2010 the firm sent out a second Urgent Medical Device Recall Notice. This notice expanded the scope of the recall to include all products distributed within the past 12 months. The shelf life of the product is 1 year -so the recall was for all product currently in the supply chain. The letter again directed consignees to locate the recalled products and contact Stryker to arrange return shipment of the recalled product. The firm sent an additional letter dated 9/1/2010 to its customers. This letter stated that Stryker will no longer be offering any of their PainPump2 products.
- Quantity
- 54,568 all products
- Distribution
- Worldwide Distribution -- US, Canada, and Australia.
- Lot, serial or model codes
- '09234012, '09241012, '09246012, '09258012, '09262012, '09283012, '09289012, '09290012, '09292022, '10012012, '10013012, '10014012, '10015012, '10018022, '10019012, '10021012, '10028012, '10029012, '10032022, '10033012, '10039022, '10040012, '10152022, '10153012, '10188012, and '10203012.
- 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