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U.S. Department of Health and Human Services

Class 2 Device Recall Curaplex

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  Class 2 Device Recall Curaplex see related information
Date Initiated by Firm October 11, 2023
Date Posted November 21, 2023
Recall Status1 Open3, Classified
Recall Number Z-0368-2024
Recall Event ID 93237
510(K)Number K012842  
Product Classification Ventilator, emergency, manual (resuscitator) - Product Code BTM
Product Curaplex manual resuscitators with integrated manometer, multiple accessory configurations to include:

1. Curaplex Adult Premium BVM with Bag Reservoir, Manometer, Filter, Peep Valve & Mask, REF # 2442-BVMPAD;

2. Curaplex Child Premium BVM with Bag Reservoir, Manometer, 25cm Pop-off, Filter & Mask, REF # 2442-BVMPCH;

3. Curaplex Child Premium BVM with Bag Reservoir, Manometer, 25cm Pop-off, Filter, Infant and Neonate Mask, REF # 2442-BVMCIN;

4. Curaplex Infant Premium BVM with Bag Reservoir, Manometer, 25cm Pop-off, Filter & 2 Masks, REF # 2442-BVMPIN;

5. Curaplex Small Adult Pediatric Premium BVM with Bag Reservoir, Manometer, 25cm Pop-off, Filter, PEEP Valve and 2 Masks, REF # 2442-BVMPSA.
Code Information UDI-DI: 00810071633126, Item # 2442-BVMCIN; UDI-DI: 00812277037050, Item # 2442-BVMPAD; UDI-DI: 00812277037074, Item # 2442-BVMPCH; UDI-DI: 00812277037081, Item # 2442-BVMPIN; UDI-DI: 00812277037067, Item # 2442-BVMPSA. All lots manufactured from 9/21/2018 to present. Latest expiration Date 10/11/2028.
Recalling Firm/
Manufacturer		 SunMed Holdings, LLC
2710 Northridge Dr Nw Ste A
Grand Rapids MI 49544-9112
For Additional Information Contact Jessica Hoke
800-433-2797
Manufacturer Reason
for Recall		 A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
FDA Determined
Cause 2		 Device Design
Action Customer notification was emailed October 11, 2023 advising customers that monitoring of tidal carbon dioxide in critically ill patients is recommended because use of accessories (e.g. PEEP valve) on the exhalation port of manual resuscitators may increase backward leak in the integrated manometer due to increased expiratory resistance. This affects all lots with duckbill-style patient valve with integrated manometer manufactured since 09/21/2019. Customers are to disseminate this information to all users and complete and return the response for. The notice also notes manual resuscitator IFUs will be updated to include this information as a warning statement.
Distribution US Nationwide distribution including in the states of AR, AZ, CA¿CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MN, NC, ND, NH, NJ, NM, NV, NY, OH, SC, TN, TX, UT, VA, & WV.
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 = BTM and Original Applicant = VENTLAB CORP.
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