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Busse Hospital Disposables, Inc. Recall 90072

Description: 4.5 MM Pellet Insertion Tray Catalog Number: B8121R1

Busse Hospital Disposables, Inc. Recall 90072 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1199-2022
Event ID90072
Event Description4.5 MM Pellet Insertion Tray Catalog Number: B8121R1
Product TypeDevices
DistributionNationwide
Quantity99 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: 2031076 2130823 UDI:00849233017306
Center Classification Date20220528
Recall Initiation Date20220222
Recalling FirmBusse Hospital Disposables, Inc.
Initial Notification Letter
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