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Stradis Healthcare Recall 91350

Description: HCT MAX BARRIER PICC INSERTION TRAY 12 per case. Distributed by Health Care Technology

Stradis Healthcare Recall 91350 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0941-2023
Event ID91350
Event DescriptionHCT MAX BARRIER PICC INSERTION TRAY 12 per case. Distributed by Health Care Technology
Product TypeDevices
DistributionUS Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.
Quantity200 units
Recall ReasonPotential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
Device Classification20230118
Device Code InfoAssembly Number HCT8428CP-2, UDI-DI: M752HCT8428CP20, Lot Number: 222218373
Center Classification Date20230111
Recall Initiation Date20221215
Recalling FirmStradis Healthcare
Initial Notification E-Mail
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