The Recall Desk
HighFDA (Devices)·Z-2714-2016·Announced 2016-09-14

Best Sanitizers Recalls Acecide-C High Level Disinfectant Due to Acid Degradation

Best Sanitizers Inc is recalling specific lots of Acecide-C High Level Disinfectant & Sterilant because the acid solution is degrading faster than normal.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a 'High' severity score (3) when no specific hospitalizations or severe injuries are reported in the source text, fitting the criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Best Sanitizers Inc is voluntarily recalling certain lots of Acecide-C High Level Disinfectant & Sterilant, 875 mL. The recall is being conducted because the acid solution in these specific lots is degrading faster than normal. The product is packaged in master cartons containing six inner cartons, with each inner carton holding a banded set of two liquids: one acid and one buffer.

The recall affects 3,023 cases in the United States and 666 cases shipped to Canada, where the product is sold as an over-the-counter drug. In the US, the product was distributed to one account in Pennsylvania. In Canada, the product was distributed to one account, with specific lots shipped to Olympus. The affected lot numbers include 16012ACE, 16036ACE, 16015ACE, 16040ACE, 16019ACE, 16043ACE, 16022ACE, 16048ACE, 16026ACE, 16050ACE, and 16033ACE, with expiration dates ranging from January 2017 to February 2017.

Consumers and healthcare facilities should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be removed from use and returned to the supplier or disposed of according to local regulations. The FDA has classified this as a Class II recall, indicating that use of or exposure to the product could cause temporary or medically reversible health consequences.

The recalled product

Product
Acecide-C High Level Disinfectant & Sterilant 875 mL. Packaging is 6 inner cartons in one master carton;1 inner carton consists of a set of two liquids (1 acid & 1 buffer) banded together.
Manufacturer
Best Sanitizers Inc
Category
Medical Device — Disinfectant
Hazard

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 (12)

  • Lot Numbers: 16012ACE EXP 01/17
  • 16036ACE EXP 02/17
  • 16015ACE EXP 01/17
  • 16040ACE EXP 02/17
  • 16019ACE EXP 01/17
  • 16043ACE EXP 02/17
  • 16022ACE EXP 01/17
  • 16048ACE EXP 02/17
  • 16026ACE EXP 01/17
  • 16050ACE EXP 02/17
  • 16033ACE EXP 02/17. Lot Numbers 16015ACE EXP 01/17
  • 16036ACE EXP 02/17 were shipped to Olympus in Canada

Distribution

Distributed in 1 state:

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