Dressing change tray recalled for sterility assurance failure
Busse Hospital Disposables recalls sterile dressing change trays due to inability to guarantee required sterility assurance level. The defect could lead to serious infections including blood stream, urinary tract, or respiratory infections.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I recall for confirmed sterility failure that cannot meet required assurance levels. The non-sterile medical device poses documented risk of serious patient infections including blood stream infections, urinary tract infections, respiratory infections, and potentially sepsis or death.
Plain-English summary
Busse Hospital Disposables is recalling its Catalog No. 1443 Dressing Change Tray (Sterile, Latex Free) due to failure to guarantee the required sterility assurance level. The recall includes 536 units distributed nationwide, specifically lots 2210077, 2210112, 2310275, and 2310331 (UDI-DI 00849233010727).
The recalled kits contain Nurse Assist Sterile 0.9% Normal Saline. The firm determined that the required sterility assurance level (SAL) of 10^-6 cannot be guaranteed for these lots. Failure to meet this sterility standard is classified as an FDA Class I recall.
If used, the non-sterile product poses risks to patients, including blood stream infections, urinary tract infections, or respiratory infections. In the worst-case scenario, there is risk of sepsis or death.
The recalled product
- Product
- Catalog No. 1443 DRESSING CHANGE TRAY / STERILE - LATEX FREE
- Manufacturer
- Busse Hospital Disposables, Inc.
- Hazard
- sterility-failure
- bloodstream-infection
- urinary-tract-infection
- respiratory-infection
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI 00849233010727 Lots 2210077 2210112 2310275 2310331
Distribution
Distributed nationwide across the United States.
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