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U.S. Department of Health and Human Services

Class 2 Device Recall MEDLINE ADULT MANUAL RESUSCITATOR

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  Class 2 Device Recall MEDLINE ADULT MANUAL RESUSCITATOR see related information
Date Initiated by Firm May 24, 2018
Create Date June 09, 2018
Recall Status1 Terminated 3 on May 12, 2020
Recall Number Z-2150-2018
Recall Event ID 80201
510(K)Number K953546  
Product Classification Ventilator, emergency, manual (resuscitator) - Product Code BTM
Product MEDLINE 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
Action On 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 Commerce 40 cases
Distribution IL & OH distributors
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 = BTM and Original Applicant = MEDICAL MARKETING CONCEPTS
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