Reported Nov 6, 2024 · Ongoing
KING LTSD,SIZE 2.5, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide…
King Systems Corp. dba Ambu, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: King Systems Corp. dba Ambu, Inc. · 15011 Herriman Blvd · Noblesville, IN · 46060-4253
Is this the product you have?
- KING LTSD,SIZE 2.5, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway
- Model/Catalog NumberKKLTSD4325
- Lot codes and dates
- UD-DI
00612649212746 (Shipper Label)00612649212753 (Piece Label)
- UD-DI
- Amount recalled
- 36727 units
This recall covers 8 products
The agency filed one notice per product. You are reading one of them; the other 7 are below.
Where it was sold
- Nationwide
Why it was recalled
Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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