Elevated risk U.S. Food and Drug Administration

Busse Hospital Disposals Medical Device Kits and Trays recall: Device & Drug Safety - Potential Lack of Sterility

Recall published 2+ years ago

Device & Drug Safety - Potential Lack of Sterility

Busse Hospital Disposals Medical devices — recalled medical devices
Photo published by U.S. Food and Drug Administration with the recall notice.

The hazard: Sterility or particulate concern

This recall is about sterility assurance. It does not mean every unit is contaminated — it means the manufacturer cannot demonstrate that none of them is.

What the notice says: Busse initiated this recall in direct response to Nurse Assist LLC’s , November 6, 2023, recall of 0.9% sodium chloride irrigation USP and sterile water for irrigation USP, due to potential lack of sterility assurance, which could result in a nonsterile product.

Why it matters: The product was made or packaged in conditions that cannot assure sterility, or visible particles were found in it. For anything injected, infused or used in the eye, that is a direct route for contamination into the body.

Symptoms and when to call a doctor

Watch for fever, chills, pain, redness, swelling or discharge at an injection site, and for a red, painful or suddenly blurred eye after using an eye product. Any of these needs same-day medical attention. Do not wait to see whether it settles, and tell the clinician which product and lot you used so it can be reported against the recall.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Published
December 19, 2023
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
Busse Hospital Disposals
Product type
Medical devices
UPC codes
00849233010000, 00849233010727, 00849233011069

Products covered by this recall

Medical Device Kits and Trays

What the company announced

On November 21, 2023, Busse Hospital Disposals initiated a nationwide recall of medical device kits and trays containing (1) Nurse Assist part 6240, Stericare 100ML Sterile Saline Botle. This is the only saline contained in the trays/kits. Busse initiated this recall in direct response to Nurse Assist LLC’s , November 6, 2023, recall of 0.9% sodium chloride irrigation USP and sterile water for irrigation USP, due to potential lack of sterility assurance, which could result in a nonsterile product. In populations most at risk, such as patients who are immunocompromised, there is a possibility that the use of the affected product could potentially result in severe or life-threatening adverse events.

All distributors who are affected have been identified and notified through recall letters. The devices that have been shipped to your facility and identified as affected may be destroyed following instructions on recall letter . The recalled Busse kits/trays were manufactured and distributed to medical device distributors from July 2022 to November 2023.

The following products, which contain Nurse Assist Part#6240, Stericare 100ML Sterile Saline Botle have been recalled:

  • Catalog Number: 800 · Product Descrip􀆟on: Tracheostomy Care Tray – Sterile – Latex Free UDI: (01)00849233010000 · Lot Number: 2210099
  • Catalog Number: 2210135
  • Catalog Number: 2210337
  • Catalog Number: 2210377
  • Catalog Number: 2310181
  • Catalog Number: 2310233
  • Catalog Number: 2310291
  • Catalog Number: 1443 · Product Descrip􀆟on: Dressing Change Tray – Sterile – Latex Free UDI: (01)00849233010727 · Lot Number: 2210077
  • Catalog Number: 2210112
  • Catalog Number: 2310275
  • Catalog Number: 2310331
  • Catalog Number: 9251R1 · Product Descrip􀆟on: Tracheostomy Care Set – Sterile – Latex Free UDI: (01)00849233011069 · Lot Number: 2210087
  • Catalog Number: 2210165
  • Catalog Number: 2310361

Products can be identified by locating the information above on their respective labeling – see reference below.

To date, Busse has not received any reports of serious injuries or deaths associated with this recall. Busse has notified both the FDA and affected distributors of the recall through direct communications. We remain commited to ensuring the safety and well-being of our customers.

Customers with any questions may contact Busse Hospital Disposables via telephone at 800-645-6526 Monday through Friday between the hours of 8am and 4pm (est) or via email at [email protected] .

Customers may also contact Nurse Assist, LLC via telephone at 800-649-6800 Monday through Friday between the hours of 8am and 430pm (cst) or via e-mail at [email protected] .

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online: www.fda.gov/medwatch/report.htm

Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

Check your product

The notice names 15 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00849233010000
  • 00849233010727
  • 00849233011069

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 2210099
  • 2210077
  • 2210087

Model or item number

On the rating label, the box or the instruction sheet.

  • 6240
  • 800
  • 2210135
  • 2310181
  • 1443
  • 2210112
  • 9251R1
  • 2210165

Package size

Match the net weight or the piece count on the front of the pack.

  • 100 ML

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Sterility

Busse Hospital Disposals — This recall is about sterility assurance. It does not mean every unit is contaminated — it means the manufacturer cannot demonstrate that none of them is.

  1. Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.
  2. Report any infection or reaction you think the product caused to FDA MedWatch.
  3. Do not use a vial or syringe with visible particles, cloudiness or discolouration, whether or not it is on the recall list.
  4. Call your prescriber or pharmacy today about a replacement from an unaffected lot — do not simply skip doses of a medicine you depend on.

Refunds and replacements

With medicines, a replacement supply matters more than cash, and that is what pharmacies are set up to provide.

  • Ask the dispensing pharmacy for a like-for-like replacement from an unaffected lot. This is the fastest route and usually costs nothing.
  • For a mail-order or online pharmacy, use the recall line listed on this page rather than the general support queue.
  • If the recall voided a fill you had already paid for, your insurer will normally authorise a replacement ahead of schedule. Quote the recall number.
  • If you paid out of pocket, ask for a refund of the co-pay or purchase price and keep the receipt the pharmacy issues.

Company contact: Busse Hospital Disposals — Consumers: Busse Hospital Disposables, 800-645-6526, [email protected]

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Busse Hospital Disposals medical devices recalled?

Device & Drug Safety - Potential Lack of Sterility Busse initiated this recall in direct response to Nurse Assist LLC’s , November 6, 2023, recall of 0.9% sodium chloride irrigation USP and sterile water for irrigation USP, due to potential lack of sterility assurance, which could result in a nonsterile product.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00849233010000, 00849233010727, 00849233011069; lot code 2210099, 2210077, 2210087; model number 6240, 800, 2210135. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.

Can I get my money back?

Ask the dispensing pharmacy for a like-for-like replacement from an unaffected lot. This is the fastest route and usually costs nothing.

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