Stryker PainPump2 BlockAid 400 mL PainPump for Continuous Nerve Block, sterile, REF 575-100, Stryker Instruments, Kalamazoo, MI. Delivers controlled amounts of medication and narcotics.
This recall has been terminated (originally issued September 28, 2010).
- Recall Initiated
- September 2, 2010
- Posted
- September 28, 2010
- Terminated
- April 21, 2011
- Recall Number
- Z-2593-2010
- Quantity
- 54,568 all products
- Firm Location
- Kalamazoo, MI
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Worldwide Distribution -- US, Canada, and Australia.
Lot / Code Info
09231012, '09233012, '09236022, '09237012, '09239022, '09243022, '09244012, '09245012, '09247012, '09252022, '09253012, '09254012, '09257022, '09260012, '09261012, '09264022, '09265012, '09268012, '09268022, '09271022, '09274012, '09275012, '09278022, '09279012, '09281012, '09282012, '09285022, '09286012, '09287012, '09288012, '09294012, '09295012, '09296012, '09299022, '09300012, '09302012, '09303012, '09306022, '09307012, '09343022, '09344012, '09345012, '09346012, '09348022, '09349012, '09350012, '09351012, '09352012, '09355012, '09356012, '09357012, '09362012, '09363012, '09364012, '10004022, '10005012, '10008012, '10011022, '10012012, '10013012, '10015012, '10019012, '10020012, '10021012, '10022012, '10025012, '10026012, '10027012, '10028012, '10041022, '10042012, '10043022, '10048012, '10049012, '10053022, and '10054022.
Root Cause
Nonconforming Material/Component
Action Taken
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.