Z-0368-2024Class II
Curaplex manual resuscitators with integrated manometer, multiple accessory configurations to include: 1...
Salter Labs / initiated 2023-10-11 / Open, Classified / root cause: design
SunMed Holdings, LLC began a recall of Curaplex manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. Curaplex Adult Premium BVM with Bag Reservoir... on . FDA classified it as Class II and gives the reason as "A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing". As of , the recall status on record is Open, Classified, and MDM tags the root cause as design.
Recall record
- Recall number
- Z-0368-2024
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Salter Labs
- 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.
- Product code
- BTM Ventilator, Emergency, Manual (Resuscitator)
- Reason for recall
- A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
- Root cause tag
- design
- FDA root cause
- 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.
- Product codes and lots
- 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.
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0361-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0362-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0363-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0364-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0365-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0366-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0367-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0368-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0369-2024 | Class II | Ongoing | Voluntary: Firm initiated |
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