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Class 1 Device Recall Minor Laceration Tray |
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Date Initiated by Firm |
October 08, 2014 |
Date Posted |
December 16, 2014 |
Recall Status1 |
Terminated 3 on August 14, 2017 |
Recall Number |
Z-0256-2015 |
Recall Event ID |
69448 |
Product Classification |
General surgery tray (kit) - Product Code LRO
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Product |
Minor Laceration Tray, Catalog number 900-1765.
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. |
Code Information |
Lot numbers: 111113039 111123389 112010093 112020412 112030646 112041203 112051652 112051882 112062451 112062568 112093753 112114887 113036455 113047208 113057433 113057863 113078277 113088761 113099393 113109754 131110201 131210683 131210763 140111120 140312090 140512615 140513043 140613601 140613631 1121114534 |
Recalling Firm/ Manufacturer |
Customed, Inc Calle Igualdad Final #7 Fajardo PR 00738
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For Additional Information Contact |
787-622-5151
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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.
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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 |
66200 |
Distribution |
US Distribution to Florida, New York and Puerto Rico.. |
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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