Date Initiated by Firm | July 10, 2015 |
Date Posted | September 03, 2015 |
Recall Status1 |
Terminated 3 on April 12, 2017 |
Recall Number | Z-2576-2015 |
Recall Event ID |
71721 |
Product Classification |
General surgery tray (kit) - Product Code LRO
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Product | PREMIUM LAPAROTOMY PK CUSTOMED 6/CS
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
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Code Information |
Code:9001296 Lots: 140915095 exp. 2/28/19 141115975 exp. 11/30/15 150116734 exp. 1/31/16 150116736 exp. 2/28/16 150116737 exp. 2/28/16 150116739 exp. 2/28/16 150116738 exp. 2/28/16 150116735 exp. 2/28/16 150217232 exp. 2/28/16 150217230 exp. 2/28/16 150217233 exp. 2/28/16 150217234 exp. 3/31/16 150217235 exp. 3/31/16 150217231 exp. 3/31/16 150317683 exp. 3/31/16 150317684 exp. 3/31/16 150317685 exp. 3/31/16 150317686 exp. 4/30/16 150317687 exp. 4/30/16 150418285 exp. 4/30/16 150418286 exp. 4/30/16 150418287 exp. 4/30/16 150418288 exp. 4/30/16 150418289 exp. 4/30/16 150518634 exp. 5/31/16 150518635 exp. 5/31/16 150519022 exp. 5/31/16 150519023 exp. 5/31/16 |
Recalling Firm/ Manufacturer |
Customed, Inc Calle Igualdad Final #7 Fajardo PR 00738
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Manufacturer Reason for Recall | Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. |
FDA Determined Cause 2 | Packaging |
Action | Customed issued an "URGENT VOLUNTARY MEDICAL DEVICE RECALL" notification letter dated July 10, 2015 to all affected customers. The letter identified the product, problem, and actions to be taken by the customer. |
Quantity in Commerce | 508 packs |
Distribution | Distributed Only in 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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