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Bard Access Systems Inc. Recall 88057

Description: 5 Fr IR PowerPICC Convenience Kit Catheter Dual Lumen with 70 cm Guidewire Unit Label: PowerPICC REF CK000340B BARD MYPICC KIT 5F French Size Dual-Lumen 70cm Guidewire

Bard Access Systems Inc. Recall 88057 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1994-2021
Event ID88057
Event Description5 Fr IR PowerPICC Convenience Kit Catheter Dual Lumen with 70 cm Guidewire Unit Label: PowerPICC REF CK000340B BARD MYPICC KIT 5F French Size Dual-Lumen 70cm Guidewire
Product TypeDevices
DistributionU.S. Nationwide distribution in the state of RI.
Quantity30 kits
Recall ReasonCatheter convenience kits contain the incorrect guidewire. Kits were labeled with 70cm guidewires, but contained a 50cm guidewire.
Device Classification20210707
Device Code InfoCatalog (REF) Number: CK000340B UDI Code: (01)00801741126697 Lot Number: 20BBK658
Center Classification Date20210701
Recall Initiation Date20210519
Recalling FirmBard Access Systems Inc.
Initial Notification Letter
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