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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Cournand Modified 2PC 19 gauge, 5.4 centimeter guidewire introducer needles

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  Class 2 Device Recall Stryker Cournand Modified 2PC 19 gauge, 5.4 centimeter guidewire introducer needles see related information
Date Initiated by Firm November 23, 2015
Date Posted December 14, 2015
Recall Status1 Terminated 3 on September 06, 2016
Recall Number Z-0417-2016
Recall Event ID 72775
510(K)Number K812973  
Product Classification Introducer, catheter - Product Code DYB
Product Cournand Modified 2-PC 19G, 5.4cm or (Guidewire Introducer Needle)
20 units per case
The Stryker Guidewire Introducer Needles are designed for the percutaneous puncture of the anterior/posterior wall of a blood vessel. This provides an entry for a guidewire, vessel dilator, sheath, and catheter introduction.
Code Information Model Number(s): 0910-192-000 Lot Numbers Affected 61406007 expiration date: 8/31/2015
Recalling Firm/
Manufacturer
Stryker Instruments Div. of Stryker Corporation
4100 E Milham Ave
Portage MI 49002-9704
For Additional Information Contact Kelly Jo Davis
269-389-2921
Manufacturer Reason
for Recall
The Guidewire Introducer Needle (0910-192-000) was shipped after the documented expiration date or with minimal time until expiration. There is a potential risk of a soft tissue infection to the patient if device is used after expiration date.
FDA Determined
Cause 2
Process control
Action Stryker sent an Urgent Medical Device Recall Notification letter dated November 24, 2015, to all affected customers via courier with instructions for identifying and returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. For questions regarding this recall, please contact Stryker Instruments: Monday-Friday 8am-5pm (EST) 269-389-2921
Quantity in Commerce 120 units
Distribution Nationwide Distribution including PA and SC.
Total Product Life Cycle TPLC Device Report

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.
510(K) Database 510(K)s with Product Code = DYB and Original Applicant = DIP, INC.
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