Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall ERREBOA PLUS Catheter

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall ERREBOA PLUS Catheter see related information
Date Initiated by Firm October 29, 2020
Create Date December 23, 2020
Recall Status1 Terminated 3 on January 11, 2023
Recall Number Z-0716-2021
Recall Event ID 86797
510(K)Number K193440  
Product Classification Catheter, intravascular occluding, temporary - Product Code MJN
Product PryTime Medical - ER-Reboa Plus Catheter, Ref: ER7232PLUS, Guidewire Free, Compatabel with 7Fr introducer Sheaths, Arterial Line, Rx Only, UDI: (01) 0 0850001 10505 7 - Product Usage: intended for temporary occlusion of large vessels and blood pressure monitoring including patients requiring emergency control of hemorrhage.
Code Information Lot # 205936
Recalling Firm/
Manufacturer		 Prytime Medical Devices, Inc.
229 N Main St
Boerne TX 78006-2035
Manufacturer Reason
for Recall		 There is a potential that catheters may have incorrectly marked balloon and arterial lines. This could result in a procedure delay or injury to the patient.
FDA Determined
Cause 2		 Labeling design
Action On October 29, 2020 the firm sent an "Urgent Medical Device Recall Notification" letter to consignees via FedEx. In addition to informing the consignees about the recall, the firm ask customers to take the following actions: 1. Please immediately quarantine and do NOT use the affected lot. 2. A Prytime representative will visit your facility and retrieve the units from the affected lot from you at that time, and return them. 3. If you have any questions or discover any additional ER-REBOA PLUS Catheters from Lot 205936 please contact me by phone at (210) 340-0116, or by email at byoung@prytimemedical.com.
Quantity in Commerce 3 units
Distribution US Nationwide distribution in the state of Utah.
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.
510(K) Database 510(K)s with Product Code = MJN and Original Applicant = Prytime Medical Devices, Inc
-
-