Date Initiated by Firm | January 07, 2016 |
Date Posted | April 14, 2016 |
Recall Status1 |
Terminated 3 on May 03, 2017 |
Recall Number | Z-1411-2016 |
Recall Event ID |
72992 |
510(K)Number | K925020 |
Product Classification |
Kit, tracheotomy care - Product Code NXA
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Product | Catalog Number: 900110 TRACHEOSTOMY CARE KIT WITH TRACH TUBE HOLDER FOR ADULT
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. |
Code Information |
LOTS: SL15170 (150619116) 30-JUN-16 SL15175 (150619116) 30-JUN-16 SV15168 (150518601) 30-JUN-16 SV15168 (150318049) 30-JUN-16 SL15199 (150719623) 31-JUL-16 SL15224 (150719623) 31-JUL-16 SL15225 (150820150) 31-AUG-16 SL15264 (150920928) 30-SEP-16 SL15264 (150920679) 30-SEP-16 SL15268 (150920928) 30-SEP-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 | Recall Notification Letter sent to direct accounts via certified mail with return receipt on January 7, 2016 and January 8, 2016. |
Quantity in Commerce | 2800 |
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 = NXA
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