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Class 2 Device Recall Dual Luer Lock Cap |
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Date Initiated by Firm |
September 10, 2013 |
Date Posted |
November 06, 2013 |
Recall Status1 |
Terminated 3 on June 05, 2015 |
Recall Number |
Z-0143-2014 |
Recall Event ID |
66249 |
Product Classification |
Port, protector/cushion - Product Code OBK
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Product |
Dual Luer Lock Cap
The device is intended for use as a cap for male or female Luer ports on medical devices such as manifolds, stopcocks or sets. |
Code Information |
10043, 10044 |
Recalling Firm/ Manufacturer |
Baxter Healthcare Corp. 1 Baxter Pkwy Deerfield IL 60015-4625
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For Additional Information Contact |
Center for One Baxter 800-422-9837
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Manufacturer Reason for Recall |
The firm is recalling lots 10043 and 10044 due to loose particulate matter found in the packaging. Particulate matter entering the fluid path from the Luer lock caps may result in embolic events.
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FDA Determined Cause 2 |
Employee error |
Action |
Baxter sent an Urgent Product Recall notification dated September 16, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Customers were advised to :
1. Locate and remove all affected product from your facility. If you distribute these products to other facilities or departments within your institution, please forward a copy of this communication to ensure that they locate and remove affected product from potential use.The product code and lot number can be found on the shipping carton label and individual product package.
2. Acknowledge your receipt of this recall notification by completing the attached Customer Reply Form (Attachment 1) and returning it to Baxter by either faxing it to 1-224-270-5457 or scanning and emailing it to fca@baxter.com. Returning the Customer Reply Form promptly will prevent you from receiving repeat notifications.
3. The affected product should be returned for credit by contacting Baxter Healthcare Center for Service. The Center for Service can be reached at 1-888-229-0001 between the hours of 7:00 am and 6:00 pm Central Time. Please have your Baxter eight-digit ship-to account number ready when calling. Please have the product code and lot number(s) available.
4.If you are a dealer, wholesaler,or distributor/reseller that distributed any product to other facilities, please forward this communication. Baxter distributed this product to customers between June 19, 2013 and August 20, 2013.
The Center for One Baxter is available at 1-800-422-9837, Monday through
Friday during the hours of 8:00 am to 5:00 pm Central Time. |
Quantity in Commerce |
628,992 units |
Distribution |
Worldwide Distribution - USA (nationwide) and the country of 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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