SUNMED AP, LTD., WAREHOUSE NO. 2
3 recall(s) on record — most severe on record: Class I.
Activity by year
- Recalls (3)
Devices registered here (1)
- Circuit, Breathing (W Connector, Adaptor, Y Piece)Product code CAI (opens in a new tab) · Class I · Anesthesiology · 21 CFR 868.5240
Recalls & enforcement
- Class IITerminated2016-03-15Stat-check CO2 indicators are non-functional. The indicator is yellow when not in use and should be purple when not in use. The yellow indicates a 5% CO2 level, cardiac massage and ventiliation being performed correctly. The color will not change during use and will not be an …
- Class ITerminated2014-05-16The pop-off valve in the defective devices remain open and a squeeze of the bag may not generate enough force to force the duck bill valve open and therefore no air will be delivered to the victim.
- Class ITerminated2012-07-11Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
Related
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)
Cite this record
RegWarden. “SUNMED AP, LTD., WAREHOUSE NO. 2 (FEI 3044994756) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3044994756-sunmed-ap-ltd-warehouse-no-2/
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