Ventlab, LLC SafeSpot manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. S
FDA device recall Z-0365-2024 · posted 2023-11-21 · Open, Classified
Recall details
- Recalling firm
- SunMed Holdings, LLC
- Reason for recall
- A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- BTM
- 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.
- Date initiated
- 2023-10-11
- Date posted
- 2023-11-21
- Location
- Grand Rapids, MI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| V*CARE MANUAL RESUSCITATOR (K012842) | Ventlab Corp. | 2001-09-18 |