FDAClass IIJune 8, 2022

SS 3.2MM Pellet Insertion Tray recall

SS 3.2MM Pellet Insertion Tray Catalog Number: B8110R1

Why was SS 3.2MM Pellet Insertion 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: 2030982 2031072 2130198 2130352 2130706 2130876 UDI: 00849233002227

Product
SS 3.2MM Pellet Insertion Tray Catalog Number: B8110R1
Recalling firm
Busse Hospital Disposables, Inc.
Quantity
300 units
Distribution
Nationwide
Recall date
June 8, 2022
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls