Date Initiated by Firm |
January 07, 2016 |
Date Posted |
April 14, 2016 |
Recall Status1 |
Terminated 3 on May 03, 2017 |
Recall Number |
Z-1458-2016 |
Recall Event ID |
72992 |
Product Classification |
Catheter and tip, suction - Product Code JOL
|
Product |
Catalog Number: 900277 SUCTION CATHETER TRAY 14FR WITH SODIUM CHLORIDE 0.9% IRRIGATION Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
|
Code Information |
LOTS: SL15175 (150518789) 30-APR-16 SL15177 (150518789) 30-APR-16 SL15180 (150619314) 30-APR-16 SL15183 (150619314) 30-APR-16 SL15232 (150820305) 31-MAY-16 SL15233 (150820305) 31-MAY-16 SL15233 (150719845) 31-MAY-16 SL15243 (150719845) 31-MAY-16 SL15268 (150920814) 31-MAY-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 |
5650 |
Distribution |
Distributed only in 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.
|