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; DYNJ901047R ORTHO SPINE FUMICH DYNJ902308K TOTAL JOINT DYNJ909111F DR SALMA'S SPINE DYNJ909117G PATTERSON TOTAL JOINT DYNJ909113F KYPHOPLASTY
DR SALMA'S SPINE DYNJ909111F UDI-DI 40198459130794 (case), 10198459130793 (ea) Lots 25FBE036 25GBV759; ORTHO SPINE FUMICH DYNJ901047R UDI-DI 40198459130466 (case), 10198459130465 (ea) Lots 25FBR230 25GBU693; PATTERSON TOTAL JOINT DYNJ909117G UDI-DI 40198459130480 (case), 10198459130489 (ea) Lots 25FBO307 25GBN625; TOTAL JOINT DYNJ902308K UDI-DI 40198459130596 (case), 10198459130595 (ea) Lots 25FBB321 25GBU688 KYPHOPLASTY DYNJ909113F UDI-DI 40198459130459 (case), 10198459130458 (ea) Lot 25IBM788
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 →