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U.S. Department of Health and Human Services

Class 1 Device Recall Irrigation Tray With Bulb Syringe

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  Class 1 Device Recall Irrigation Tray With Bulb Syringe see related information
Date Initiated by Firm October 08, 2014
Date Posted December 16, 2014
Recall Status1 Terminated 3 on August 14, 2017
Recall Number Z-0238-2015
Recall Event ID 69448
Product Classification Tray, irrigation, sterile - Product Code EYN
Product Irrigation Tray With Bulb Syringe, Catalog number 900-020.

Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Code Information Lot numbers: 111112971 111123273 112010006 112020294 112030797 112041052 112041386 112041450 112051644 112062300 112083043 112093635 113025799 113025979 113026274 113036446 113046993 113047330 113057829 113068135 113078452 113078659 113099261 131110143 140111104 140211714 140312032 140412568 140513034 140613550 140814606 140815025 
Recalling Firm/
Manufacturer		 Customed, Inc
Calle Igualdad Final #7
Fajardo PR 00738
For Additional Information Contact
787-622-5151
Manufacturer Reason
for Recall		 Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
FDA Determined
Cause 2		 Packaging
Action Customed initiated a recall on October 8th, 2014 of sterile convenience surgical Packs-trays, bags (known as Convenience Packs) and new lots of products added to the initial June 3, 2014 recall of 233 sterile surgical packs. The products are being recalled because of significant compromised sterility, not limited to potentially damaged packaging. Customers were instructed to quarantine and cease use of the affected product identified. Customers are to return the response form included with the letter, to the contact information provided. Upon receipt, the firm will contact customers with further instructions to obtain credit, replacement product, and for return of the recalled product or any other disposition action. If customers have any questions, they should contact the Customed Recall Coordinator at 407-850-5558 extensions 8001 or 8005, or via e-mail: pablo.diaz@customedhealing.com.
Quantity in Commerce 76800
Distribution US Distribution to Florida, New York and Puerto Rico..
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.
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