Aomori Olympus Co., Ltd. recalls MAJ-247 SINGLE USE 30MM REPLACEMENT BASKET, model no. MAJ-24
Recalled Product
MAJ-247 SINGLE USE 30MM REPLACEMENT BASKET, model no. MAJ-247 - Product Usage: REPLACEMENT BASKET for BML-3Q Mechanical Lithotripter.
Hazard / Issue
Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
Issued by
FDA
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