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Busse Hospital Disposables, Inc. Recall 90072

Description: Single Shot Epidural Tray Catalog Number: 6183R1

Busse Hospital Disposables, Inc. Recall 90072 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-1169-2022
Event ID90072
Event DescriptionSingle Shot Epidural Tray Catalog Number: 6183R1
Product TypeDevices
Quantity425 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: 2030967 2031172 2031272 2130029 2130151 2130298 2130357 2130459 2130527 2130593 2130716 2130863 2130975 2131088 2131120 2131224 2131248 UDI: 00849233007857
Center Classification Date20220528
Recall Initiation Date20220222
Recalling FirmBusse Hospital Disposables, Inc.
Initial Notification Letter
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