Stryker PainPump2 BlockAid 400 mL PainPump for Continuous Nerve Block, sterile, REF 575-100, Stryker Instruments, Kalama

FDA device recall Z-2593-2010 · posted 2010-09-28 · Terminated

Recall details

Recalling firm

Stryker Instruments Div. of Stryker Corporation

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.

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

FRN

Quantity affected

54,568 all products

Distribution

Worldwide Distribution -- US, Canada, and Australia.

Date initiated

2010-09-02

Date posted

2010-09-28

Date terminated

2011-04-21

Location

Kalamazoo, MI

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