Date Initiated by Firm | January 07, 2016 |
Date Posted | April 14, 2016 |
Recall Status1 |
Terminated 3 on May 03, 2017 |
Recall Number | Z-1430-2016 |
Recall Event ID |
72992 |
510(K)Number | K902886 |
Product Classification |
Drape, surgical - Product Code KKX
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Product | Catalog Number: 9001574
LEGGINS 30X42 W/7" CUFF
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. |
Code Information |
LOTS: SL15194 (150719656) 31-JUL-16 SL15223 (150820181) 31-AUG-16 SL15223 (150820180) 31-AUG-16 SL15223 (150820182) 31-AUG-16 |
Recalling Firm/ Manufacturer |
Customed, Inc Calle Igualdad Final #7 Fajardo PR 00738
|
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 | Recall Notification Letter sent to direct accounts via certified mail with return receipt on January 7, 2016 and January 8, 2016. |
Quantity in Commerce | 270 |
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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510(K) Database | 510(K)s with Product Code = KKX
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