FDAClass IIJune 8, 2022

Single Shot Epidural Tray recall

Single Shot Epidural Tray Catalog Number: 6183R1

Why was Single Shot Epidural Tray recalled?

Busse 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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Numbers: 2030967 2031172 2031272 2130029 2130151 2130298 2130357 2130459 2130527 2130593 2130716 2130863 2130975 2131088 2131120 2131224 2131248 UDI: 00849233007857

Product
Single Shot Epidural Tray Catalog Number: 6183R1
Recalling firm
Busse Hospital Disposables, Inc.
Quantity
425 units
Distribution
Nationwide
Recall date
June 8, 2022
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls