FDAClass IIJune 8, 2022

Sterile Epidural Tray recall

Sterile Epidural Tray Catalog Number: 6259R2

Why was Sterile 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: 2130839 2131167 2131230 2131210 UDI: 00849233000278

Product
Sterile Epidural Tray Catalog Number: 6259R2
Recalling firm
Busse Hospital Disposables, Inc.
Quantity
50 units
Distribution
Nationwide
Recall date
June 8, 2022
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls