Date Initiated by Firm | February 03, 2006 |
Date Posted | March 21, 2006 |
Recall Status1 |
Terminated 3 on June 04, 2007 |
Recall Number | Z-0668-06 |
Recall Event ID |
34545 |
510(K)Number | K042405 |
Product Classification |
Pump, Infusion, Pca - Product Code MEA
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Product | Stryker PainPump1.5 Base Infusion Kit; Product number 501-100-000. |
Code Information |
Lot 2005053004. |
Recalling Firm/ Manufacturer |
Stryker Instruments Div. of Stryker Corporation 4100 E Milham Ave Portage MI 49002-9704
|
For Additional Information Contact | 800-800-4236 Ext. 3808 |
Manufacturer Reason for Recall | The catheter tubing included in the kit may break during removal. |
FDA Determined Cause 2 | Other |
Action | 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. |
Distribution | Nationwide, Australia and Canada. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = MEA
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