Product Safety Recalls

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Busse Hospital Disposables, Inc. Recall 90072

Description: Female SS 3.5MM Pellet Insertion Tray Catalog Number: B1568

Busse Hospital Disposables, Inc. Recall 90072 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1194-2022
Event ID90072
Event DescriptionFemale SS 3.5MM Pellet Insertion Tray Catalog Number: B1568
Product TypeDevices
DistributionNationwide
Quantity100 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: 2130338 2130562 UDI: 00849233005525
Center Classification Date20220528
Recall Initiation Date20220222
Recalling FirmBusse Hospital Disposables, Inc.
Initial Notification Letter
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