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Female SS 3.5MM Pellet Insertion Tray recallZ-1201-2022 · Busse Hospital Disposables, Inc. · initiated Feb 22, 2022

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Busse Hospital Disposables, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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

FDA root cause category: Other

What the company is doing

Busse Hospital Disposables issued Product Recall Notification on 2/22/22 Re: PDI Prevantics Swab, Swabstick, and Maxi Swabstick Voluntary Recall stating reason for recall , health risk and action to take: Busse Hospital Disposables has initiated a voluntary recall on any products containing the affected product. However, it is important to note the integrity of the kit and other components is not compromised by the recalled PDI prevantic pouches. PDI shipped this product between February 2020 and July 2021. Please take the following actions: 1. Immediately check your inventory for the lots listed above. 2. Cease distribution and/or use of the product with the lot number(s) listed above. 3. Complete the enclosed Response Form within the next 10 days and return via email to [email protected] even if you have no affected product on hand. 4. Busse will then issue Return Goods authorization(s) to allow for product to be returned. ***Update: Firm issued a 2nd notification on 03/25/2022, as recall is extended to the user-level. Letter states: Please note that the integrity of the kit and other components are not compromised by the recalled PDI Prevantic pouches. Therefore, the kits affected may continue to be used without the PDI Prevantics Swab/Swabsticks. 1. Immediately check your inventory for the Busse kit lot numbers listed above. 2. Complete the enclosed Response Form specifying the quantity available in your stock within the next 10 days and return via email to [email protected]. If there is no Busse kits affected in your possession, please return the form noting this as well. 3. Cease use of the PDI Prevantics pouches in the Busse kits with lot number(s) listed above and discard once the kit is used/opened. An alternative skin prep swab at your disposition should be used for the procedure.

Recall details

Recall number
Z-1201-2022
Status
Terminated
Initiated by the company
Feb 22, 2022
Recalling firm
Busse Hospital Disposables, Inc.
Quantity
1040 units
Product code
FBQ
Distribution
Nationwide

Product description

Female SS 3.5MM Pellet Insertion Tray Catalog Number: B9175R1

Code information (models, lots, serial numbers)

Lot Numbers: Lot 2030875 2030980 2031048 2031048 2031096 2031048 2031096 2130563 2130722 UDI: 00849233011182

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 90072).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page