510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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Z-2592-2010

Stryker PainPump2 400 mL PainPump with Luer Lock Tubing Set, sterile, REF 540-350, Stryker Instruments...

Stryker Corp. / initiated 2010-09-02 / Terminated / root cause: manufacturing process
FDA source (opens on fda.gov)

Stryker Instruments Div. of Stryker Corporation began a recall of Stryker PainPump2 400 mL PainPump with Luer Lock Tubing Set, sterile, REF 540-350, Stryker Instruments, Kalamazoo, MI. Delivers controlled amounts of... on . The reason FDA records is "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-2592-2010
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Stryker Corp.
Product
Stryker PainPump2 400 mL PainPump with Luer Lock Tubing Set, sterile, REF 540-350, Stryker Instruments, Kalamazoo, MI. Delivers controlled amounts of medication and narcotics.
Product code
FRN Pump, Infusion
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.
Root cause tag
manufacturing process
FDA 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 in commerce
54,568 all products
Distribution
Worldwide Distribution -- US, Canada, and Australia.
Product codes and lots
'09232012, '10112032, '09238012, '10113012, '09246012, '10116022, '09259012, '10117012, '09266012, '10118012, '09280012, '10119012, '09287012, '10120012, '09300012, '10123022, '09303012, '10124012, '10005012, '10153012, '10007012, '10154012, '10008012, '10155012, '10011012, '10158022, '10047012, '10159012, '10048012, '10160012, '10049012, '10161012, '10050012, '10162012, '10074022, '10165022, '10076012, '10166012, '10077012, '10167012, '10078012, '10167022, '10081022, '10168012, '10102022, '10169012, '10103012, '10170012, '10104012, '10172022, '10105012, '10173012, '10106012, '10174012, '10109022, '10175012, '10110012, '10176012, '10111022, and '10177012.