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

I.V. Start Kit - Tegaderm Dressing - Catheter Securement recalled

Busse Hospital Disposables is recalling I.V. Start Kit - Tegaderm Dressing - Catheter Securement - Prevantics, 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: 2020514 2020525 2020734 2120255 2120304 2120325 2120439 UDI: 00849233010017

Quantity recalled2475

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-1147-2022
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: Heart & Vascular 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

I.V. Start Kit - Tegaderm Dressing - Catheter Securement - Prevantics Catalog Number: 822

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

Lot Numbers: 2020514 2020525 2020734 2120255 2120304 2120325 2120439 UDI: 00849233010017

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

Other products in this recall event

57 other products · FDA event 90072

This product is part of a recall event; the main page for the event is Pellet Insertion Tray recalled by Busse Hospital Disposables.

Reported	Class	Recall	Company	Reason	Where
8 Jun 2022	CLASS II	Pellet Insertion Tray recalled by Busse Hospital Disposables	Busse Hospital Disposables	Other	Nationwide
8 Jun 2022	CLASS II	Female SS Pellet Insertion Tray recalled by Busse Hospital Disposables	Busse Hospital Disposables	Other	Nationwide
8 Jun 2022	CLASS II	Nerve Block Tray recalled by Busse Hospital Disposables	Busse Hospital Disposables	Other	Nationwide
8 Jun 2022	CLASS II	Single Shot Epidural Tray recalled by Busse Hospital Disposables	Busse Hospital Disposables	Other	Nationwide
8 Jun 2022	CLASS II	Ss Diamond Tip Trocar With Medium Gloves recalled	Busse Hospital Disposables	Other	Nationwide
8 Jun 2022	CLASS II	SS Pellet Insertion Tray recalled by Busse Hospital Disposables	Busse Hospital Disposables	Other	Nationwide
8 Jun 2022	CLASS II	Pain Tray recalled by Busse Hospital Disposables	Busse Hospital Disposables	Other	Nationwide
8 Jun 2022	CLASS II	Core Biopsy Tray recalled by Busse Hospital Disposables	Busse Hospital Disposables	Other	Nationwide
8 Jun 2022	CLASS II	Ss Diamond Tip Trocar With Large Gloves recalled	Busse Hospital Disposables	Other	Nationwide
8 Jun 2022	CLASS II	Procedural Accessory Kit recalled by Busse Hospital Disposables	Busse Hospital Disposables	Other	Nationwide
8 Jun 2022	CLASS II	Pump Refill Kit recalled by Busse Hospital Disposables	Busse Hospital Disposables	Other	Nationwide
8 Jun 2022	CLASS II	Joint Injection Tray recalled by Busse Hospital Disposables	Busse Hospital Disposables	Other	Nationwide
8 Jun 2022	CLASS II	Lumbar Tray recalled by Busse Hospital Disposables	Busse Hospital Disposables	Other	Nationwide
8 Jun 2022	CLASS II	Universal Nerve Block Tray recalled by Busse Hospital Disposables	Busse Hospital Disposables	Other	Nationwide
8 Jun 2022	CLASS II	Nerve Block Tray recalled by Busse Hospital Disposables	Busse Hospital Disposables	Other	Nationwide
8 Jun 2022	CLASS II	Single Shot Epidural Tray recalled by Busse Hospital Disposables	Busse Hospital Disposables	Other	Nationwide
8 Jun 2022	CLASS II	Pellet Insertion Tray recalled by Busse Hospital Disposables	Busse Hospital Disposables	Other	Nationwide
8 Jun 2022	CLASS II	" Pellet Insertion Tray with Medium Gloves" recalled	Busse Hospital Disposables	Other	Nationwide
8 Jun 2022	CLASS II	SS Pellet Insertion Tray with large Gloves recalled	Busse Hospital Disposables	Other	Nationwide
8 Jun 2022	CLASS II	Sterile Epidural Tray recalled by Busse Hospital Disposables	Busse Hospital Disposables	Other	Nationwide
8 Jun 2022	CLASS II	Port Tray recalled by Busse Hospital Disposables	Busse Hospital Disposables	Other	Nationwide
8 Jun 2022	CLASS II	I.V. Start Kit recalled by Busse Hospital Disposables	Busse Hospital Disposables	Other	Nationwide
8 Jun 2022	CLASS II	SS Pellet Insertion Tray with Medium Gloves recalled	Busse Hospital Disposables	Other	Nationwide
8 Jun 2022	CLASS II	Nerve Block Tray recalled by Busse Hospital Disposables	Busse Hospital Disposables	Other	Nationwide
8 Jun 2022	CLASS II	Single Shot Epidural Tray recalled by Busse Hospital Disposables	Busse Hospital Disposables	Other	Nationwide
8 Jun 2022	CLASS II	Universal Tray recalled by Busse Hospital Disposables	Busse Hospital Disposables	Other	Nationwide
8 Jun 2022	CLASS II	SS Pellet Insertion Tray with Medium Gloves recalled	Busse Hospital Disposables	Other	Nationwide
8 Jun 2022	CLASS II	Nerve Block Tray recalled by Busse Hospital Disposables	Busse Hospital Disposables	Other	Nationwide
8 Jun 2022	CLASS II	Pellet Insertion Tray with Medium Gloves recalled	Busse Hospital Disposables	Other	Nationwide
8 Jun 2022	CLASS II	SS Pellet Insertion Tray with Large Gloves recalled	Busse Hospital Disposables	Other	Nationwide
8 Jun 2022	CLASS II	Female SS Pellet Insertion Tray recalled by Busse Hospital Disposables	Busse Hospital Disposables	Other	Nationwide
8 Jun 2022	CLASS II	SS Pellet Insertion Tray with Medium Gloves recalled	Busse Hospital Disposables	Other	Nationwide
8 Jun 2022	CLASS II	SS Pellet Insertion Tray recalled by Busse Hospital Disposables	Busse Hospital Disposables	Other	Nationwide
8 Jun 2022	CLASS II	SS Pellet Insertion Tray with large Gloves recalled	Busse Hospital Disposables	Other	Nationwide
8 Jun 2022	CLASS II	Cervical Tray recalled by Busse Hospital Disposables	Busse Hospital Disposables	Other	Nationwide
8 Jun 2022	CLASS II	Stereo Breast Biopsy Tray recalled by Busse Hospital Disposables	Busse Hospital Disposables	Other	Nationwide
8 Jun 2022	CLASS II	Pellet Insertion Tray recalled by Busse Hospital Disposables	Busse Hospital Disposables	Other	Nationwide
8 Jun 2022	CLASS II	Pellet Insertion Tray with Large Gloves recalled	Busse Hospital Disposables	Other	Nationwide
8 Jun 2022	CLASS II	SS Pellet Insertion Tray with Large Gloves recalled	Busse Hospital Disposables	Other	Nationwide
8 Jun 2022	CLASS II	Pellet Insertion Tray recalled by Busse Hospital Disposables	Busse Hospital Disposables	Other	Nationwide
8 Jun 2022	CLASS II	Bone Marrow Biopsy Tray recalled by Busse Hospital Disposables	Busse Hospital Disposables	Other	Nationwide
8 Jun 2022	CLASS II	Male SS Pellet Insertion Tray recalled by Busse Hospital Disposables	Busse Hospital Disposables	Other	Nationwide
8 Jun 2022	CLASS II	Procedure Tray recalled by Busse Hospital Disposables	Busse Hospital Disposables	Other	Nationwide
8 Jun 2022	CLASS II	Universal Nerve Block Tray recalled by Busse Hospital Disposables	Busse Hospital Disposables	Other	Nationwide
8 Jun 2022	CLASS II	SS Diamond Tip Trocar - Medium Gloves recalled	Busse Hospital Disposables	Other	Nationwide
8 Jun 2022	CLASS II	Single Shot Epidural Tray recalled by Busse Hospital Disposables	Busse Hospital Disposables	Other	Nationwide
8 Jun 2022	CLASS II	SS Pellet Insertion Tray recalled by Busse Hospital Disposables	Busse Hospital Disposables	Other	Nationwide
8 Jun 2022	CLASS II	Single Shot Epidural Tray recalled by Busse Hospital Disposables	Busse Hospital Disposables	Other	Nationwide
8 Jun 2022	CLASS II	Cervical Tray recalled by Busse Hospital Disposables	Busse Hospital Disposables	Other	Nationwide
8 Jun 2022	CLASS II	Epidural Tray recalled by Busse Hospital Disposables	Busse Hospital Disposables	Other	Nationwide
8 Jun 2022	CLASS II	CVC Dressing Change Kit recalled by Busse Hospital Disposables	Busse Hospital Disposables	Other	Nationwide
8 Jun 2022	CLASS II	Pellet Insertion Tray recalled by Busse Hospital Disposables	Busse Hospital Disposables	Other	Nationwide
8 Jun 2022	CLASS II	MBB Tray recalled by Busse Hospital Disposables	Busse Hospital Disposables	Other	Nationwide
8 Jun 2022	CLASS II	Epidural Tray recalled by Busse Hospital Disposables	Busse Hospital Disposables	Other	Nationwide
8 Jun 2022	CLASS II	SS Diamond Tip Trocar - Large Gloves recalled	Busse Hospital Disposables	Other	Nationwide
8 Jun 2022	CLASS II	Single Shot Epidural Tray recalled by Busse Hospital Disposables	Busse Hospital Disposables	Other	Nationwide
8 Jun 2022	CLASS II	Male SS Pellet Insertion Tray recalled by Busse Hospital Disposables	Busse Hospital Disposables	Other	Nationwide

More recalls from Busse Hospital Disposables

All 63

Reported	Class	Recall	Company	Reason	Where
10 Jan 2024Device	CLASS I	Catalog No. 800 Tracheostomy Care Tray - Sterile -Latex Free recalled	Busse Hospital Disposables	Sterility	Nationwide
10 Jan 2024Device	CLASS I	Catalog No. 1443 Dressing Change Tray / Sterile - Latex Free recalled	Busse Hospital Disposables	Sterility	Nationwide
10 Jan 2024Device	CLASS I	Catalog No. 9251R1, 9251R2, 9251R3 Tracheostomy Care SET / Sterile recalled	Busse Hospital Disposables	Sterility	Nationwide
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

Other Heart & Vascular Devices recalls

All 6,199

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled	Atrium Medical	Potency & Assay	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes: *Bardex¿ I.C recalled	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Firm PVC Straight recalled	Atrium Medical	Potency & Assay	Nationwide