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Aomori Olympus Co., Ltd. Recall 87074

Description: INJECTOR FORCEMAX 25G 2.5MM, model no. NM-400U-0425 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.

Aomori Olympus Co., Ltd. Recall 87074 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1018-2021
Event ID87074
Event DescriptionINJECTOR FORCEMAX 25G 2.5MM, model no. NM-400U-0425 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
Product TypeDevices
DistributionUS Nationwide distribution.
Quantity7,400,000 (globally); 260,395 (US)
Recall ReasonInspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
Device Classification20210217
Device Code Info01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV
Center Classification Date20210205
Recall Initiation Date20210104
Recalling FirmAomori Olympus Co., Ltd.
Initial Notification Letter
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