Product Safety Recalls

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Synaptive Medical Inc Recall 87937

Description: Synaptive Trackable Suction Set Standard and Malleable

Synaptive Medical Inc Recall 87937 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1955-2021
Event ID87937
Event DescriptionSynaptive Trackable Suction Set Standard and Malleable
Product TypeDevices
DistributionDomestic Distribution: IN, SC, MD, OR, TX ,LA, MI, NY, NV, FL, VA, CA,WI, PA and NC. International Distribution: Australia, Canada, Belgium, Netherlands, Singapore, Switzerland, Thailand, UK, Vietnam
Quantity1291 units
Recall ReasonDue to visible burrs/metal filings affixed along the suction tube inner perimeter.
Device Classification20210707
Device Code InfoSet and components codes: SYN-0657, SYN-0783 Consumables 3 Packs SYN-0663, SYN-0664, SYN-0665, SYN-0666, SYN-0667, SYN-0668, SYN-0759, SYN-0760, SYN-0761, SYN-0762, SYN-0763, SYN-0764, SYN-0765 and SYN-0766. Consumables Singles SYN- 0651, SYN-0652, SYN-0653, SYN-0654, SYN-0655, SYN-0656, SYN-0671,SYN-0672, SYN-0673, SYN-0674, SYN-0675, SYN-0676, SYN-0677 and SYN-0778. All lots and all serial numbers.
Center Classification Date20210625
Recall Initiation Date20210423
Recalling FirmSynaptive Medical Inc
Initial Notification E-Mail
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