| Class 2 Device Recall | |
Date Initiated by Firm | April 18, 2019 |
Date Posted | May 31, 2019 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-1554-2019 |
Recall Event ID |
82703 |
510(K)Number | K080592 |
Product Classification |
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass - Product Code DWF
|
Product | Maquet Getinge-BEQ-TOP 25003 3/8X3/8 TO 7LPM
Material: 701063255 |
Code Information |
Batch Numbers: 3000041007 3000044052 3000045730 3000047318 3000054334 3000054615 3000063091 |
Recalling Firm/ Manufacturer |
Maquet Cardiovascular, LLC 45 Barbour Pond Dr Wayne NJ 07470-2094
|
Manufacturer Reason for Recall | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured |
FDA Determined Cause 2 | Device Design |
Action | Maquet Getinge issued recall notification letter on April 18, 2019 via FedEx 2-day delivery identifies issue, health risk and action to take: quarantine and return to Maquet/Getinge recalled product. Complete response form and return to acknowledge this recall. Questions contact Getinge Customer Service at 18886278383 (press option 2, then option 2) between the hours of 8 AM and 6 PM Eastern Standard Time.
On 3/26/20 firm expanded recall to include an additional lot for one consignee,product: "BEQTOP 25003 3/8 3/8 up to 7 lpm", item number 701063255R02, lot 3000087051. |
Distribution | Nationwide |
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
510(K) Database | 510(K)s with Product Code = DWF
|
|
|
|