INTEGRATED MEDCRAFT LLC
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
Devices could potentially contain an occluded or partially occluded Guedel Airway tip.
FORWARD Oral Airway Kit (OPA Sizes 5, 6.5, 7, 8, 9, 10, 12). REF Number: 1011-40002. Containing the affected One-piece Guedel airway components: 1. Size 00, ISO 5.0, blue. Product Code: 1100050. 2. Size 000, ISO 3.5, light green. Product Code: 1000035.
FORWARD Oral Airway Kit (OPA Sizes 5, 6.5, 7, 8, 9, 10, 12). REF Number: 1011-40002. Lot Numbers: IMC-00000060, IMC-00000066, IMC-00000078, IMC-00000086, IMC-00000092, IMC-00000096, IMC-00000096, IMC-00000097, IMC-00000103, IMC-00000110, IMC-00000125, IMC-00000151, IMC-00000200, IMC-00000201, IMC-00000204, IMC-00000205. Containing the affected One-piece Guedel airway components: 1. Size 00, ISO 5.0, blue. Product Code: 1100050. Lot Numbers: 32121232, 32208193, 32400267, 32403734, 32408819, 32409672, 32416545, 32427064, 32605471, 32606405, 32606850, 32607154. 2. Size 000, ISO 3.5, light green. Product Code: 1000035. Lot Numbers: 32190425, 32213076, 32221283, 32307261, 32317627, 32321305, 32513841, 32517565
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →