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Acecide-C High Level Disinfectant & Sterilant 875 mL.… recallZ-2714-2016 · Best Sanitizers Inc · initiated Aug 2, 2016

Class II Terminated All recalls posted in September 2016

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Best Sanitizers Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Certain lots of the acid solution in Acecide-C are degrading faster than normal.

FDA root cause category: Nonconforming Material/Component

What the company is doing

Customer letters dated 8/2/16 will be sent.

Recall details

Recall number
Z-2714-2016
Recall class
Class II
Status
Terminated
Initiated by the company
Aug 2, 2016
Posted by the FDA
Sep 2, 2016
Recalling firm
Best Sanitizers Inc
Quantity
3,023 cases USA; 666 cases shipped to Canada (OTC drug there)
Product code
MED
FDA submissions
K091210
Distribution
Distributed to one (1) account in the state of PA. Distributed to one (1) account in Canada

Product description

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.

Code information (models, lots, serial numbers)

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

Other devices under the same FDA submission

1 device cleared under K091210 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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