Medline Industries, LP
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.
Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment.
Convenience Kits: DYNJ901048N ORTHO SPINE ST CLAIR DYNJ909123F UROLOGY MINOR DYNJ909132F SET UP DYNJ909308D HIP PINNING
HIP PINNING DYNJ909308D UDI-DI 40198459055288 (case), 10198459055287 (ea) Lots 25FBB311 25GBC282 25GBW486; ORTHO SPINE ST CLAIR DYNJ901048N UDI-DI 40198459055554 (case), 10198459055553 (ea) Lots 25GBQ070; SET UP DYNJ909132F UDI-DI 40198459130572 (case), 10198459130571 (ea) Lots 25GBI845 25IBF708; UROLOGY MINOR DYNJ909123F UDI-DI 40198459130602 (case), 10198459130601 (ea) Lots 25GBT826 25IBF707
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 →