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Bard Peripheral Vascular Inc Recall 90201

Description: REF: PIG1260K, 6Fr, X10, Safe-t-Centesis Catheter drainage Kit, Sterile EO,

Bard Peripheral Vascular Inc Recall 90201 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1273-2022
Event ID90201
Event DescriptionREF: PIG1260K, 6Fr, X10, Safe-t-Centesis Catheter drainage Kit, Sterile EO,
Product TypeDevices
DistributionWorldwide distribution - US Nationwide distribution in the states of MS, NC, FL, KS, GA, OH, AZ, NV, OH, IL, MI, MO,IA, CA, PA, AL,WA, TN, IN, NY and the countries of AU, BE, NZ.
Quantity1460 units
Recall ReasonThere is the potential that a 6 Fr Catheter Drainage kit contains an 8 Fr needle instead of a 6 Fr needle. They can be used in conjunction with the following drainage methods: Universal extension set and drainage bag, vacuum bottle, and wall suction.
Device Classification20220629
Device Code InfoLot # 0001405396; UDI/DI: (01)10885403076114
Center Classification Date20220621
Recall Initiation Date20220422
Recalling FirmBard Peripheral Vascular Inc
Initial Notification Letter
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