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Busse Hospital Disposables, Inc. Recall 90072

Description: Single Shot Epidural Tray Catalog Number: 8417

Busse Hospital Disposables, Inc. Recall 90072 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-1159-2022
Event ID90072
Event DescriptionSingle Shot Epidural Tray Catalog Number: 8417
Product TypeDevices
Quantity400 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: 2130077 2130313 2130630 2130945 2131091 UDI: 00849233016804
Center Classification Date20220528
Recall Initiation Date20220222
Recalling FirmBusse Hospital Disposables, Inc.
Initial Notification Letter
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