Recalls / —

—#44062

Product

Stryker PainPump1 2-Site Y-Connector; Product number 500-200-000.

FDA product code

MEA — Pump, Infusion, Pca

Device class

Class 2

Medical specialty

General Hospital

510(k) numbers

K042405

Affected lot / code info

Lot 2005052501.

Why it was recalled

The catheter tubing included in the kit may break during removal.

Root cause (FDA determination)

Other

Action the firm took

Each consignee was notified of the recall via recall letter dated 2/7/06, which requested that they destroy the affected lots on site. International accounts were notified via email.

Recalling firm

Firm

Stryker Instruments Div. of Stryker Corporation

Address

4100 E Milham Ave, Portage, Michigan 49002-9704

Distribution

Distribution pattern

Nationwide, Australia and Canada.

Timeline

Recall initiated

2006-02-03

Posted by FDA

2006-03-21

Terminated

2007-06-04

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #44062. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.