Product Safety Recalls

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Busse Hospital Disposables, Inc. Recall 90072

Description: I.V. Start Kit Catalog 8172

Busse Hospital Disposables, Inc. Recall 90072 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1157-2022
Event ID90072
Event DescriptionI.V. Start Kit Catalog 8172
Product TypeDevices
DistributionNationwide
Quantity4218 units
Recall ReasonBusse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
Device Classification20220608
Device Code InfoLot Numbers: 2020561 2020560 2020650 2120089 2120018 2120344 2120442 2120645 2120768 2120911 UDI: 00849233015883
Center Classification Date20220528
Recall Initiation Date20220222
Recalling FirmBusse Hospital Disposables, Inc.
Initial Notification Letter
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