CLASS II Device recall · Reported 8 Jun 2022 · FDA Enforcement Report

Procedural Accessory Kit recalled by Busse Hospital Disposables

Busse Hospital Disposables is recalling Procedural Accessory Kit, distributed nationwide in the US. The recall was initiated on 22 Feb 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Numbers: 2031038 UDI: 00860000210461

Quantity recalled250 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1178-2022
FDA event ID: 90072
Recalling firm: Busse Hospital Disposables, Hauppauge, NY
Classification: Class II
Status: Terminated
Recall initiated: 22 Feb 2022
FDA classified: 28 May 2022
Reported: 8 Jun 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

22 Feb 2022	Recall initiated by company
28 May 2022	Classified by FDA	+95 days
8 Jun 2022	Published in enforcement report	+11 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

Procedural Accessory Kit Catalog Number: 9665R2

Where it was distributed

Nationwide

Questions about this recall

Is Procedural Accessory Kit recalled?

Yes. Busse Hospital Disposables recalled Procedural Accessory Kit on 22 Feb 2022. The recall is Class II and its status is Terminated. Recall number Z-1178-2022.

Why was it recalled?

Which lots are affected?

Lot Numbers: 2031038 UDI: 00860000210461

Where was it sold?

Nationwide

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Busse Hospital Disposables

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7 Dec 2022Device	CLASS II	Busse Spine Injection Tray-Intended as a nerve block recalled	Busse Hospital Disposables	Other	TX
7 Dec 2022Device	CLASS II	Busse Joint Injection Tray -Intended as a nerve block recalled	Busse Hospital Disposables	Other	TX

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