• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall MEDLINE ADULT MANUAL RESUSCITATOR

  • 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 MEDLINE ADULT MANUAL RESUSCITATORsee related information
Date Initiated by FirmMay 24, 2018
Create DateJune 09, 2018
Recall Status1 Terminated 3 on May 12, 2020
Recall NumberZ-2150-2018
Recall Event ID 80201
510(K)NumberK953546 
Product Classification Ventilator, emergency, manual (resuscitator) - Product Code BTM
ProductMEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR, PEEP VALVE, CO2 AND 7 FT. OXYGEN TUBING, REF CPRM1116PC
Code Information Lot Number: 313235
Recalling Firm/
Manufacturer
Sun Med, LLC
2710 Northridge Dr NW Ste A
Grand Rapids MI 49544-9112
For Additional Information Contact
800-433-2797
Manufacturer Reason
for Recall
There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
FDA Determined
Cause 2
Mixed-up of materials/components
ActionOn May 25, 2018 Sun Med, LLC issued URGENT MEDICAL DEVICE PRODUCT REMOVAL notices to two of their customers. On June 1, 2018 Sun Med, LLC issued a press release. Customers were encouraged to take the following actions: 1) Examine inventory, quarantine and cease distribution of impacted product. 2) If customers further distributed product, please identify your customers/consignees and notify them of this product removal. Your notification may be enhanced by including a copy of the removal notice. If you need any assistance contacting your customers, please inform SunMed. 3) Complete and return the Removal Return Response Form via fax to 1-800-400-8820 or via email to info@sun-med.com as soon as possible. 4) Once you return the affected product(s), new corrected replacement resuscitation bags will be provided to you. If you need replacement products to be sent to you urgently, please call SunMed directly. Customers with questions can call 1-800-433-2797 or email info@sun-med.com
Quantity in Commerce40 cases
DistributionIL & OH distributors
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = BTM
-
-