American Surgical Sponges Recalled for Packaging Defect Compromising Sterility
American Surgical Company is recalling Americot Blue sponges because defective packaging may compromise sterility. The recall covers 54 cases distributed worldwide.
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 involves a risk-of-harm product (sterile medical device) where the defect compromises sterility, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
American Surgical Company is recalling 54 cases of Americot Blue 1/4" x 1/4" sponges (Ref Number: 20-01S). These neurosurgical and nonneurosurgical sponges are being recalled because the product packaging is defective, which may compromise the sterility of the devices.
The affected lots are 2015/09 AB, 2015/12 BS, 2015/12 BN, and 2016/01 AC. The products were distributed nationwide in the United States and internationally to Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Israel, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and the United Kingdom.
Healthcare providers and consumers should stop using these sponges and contact American Surgical Company for further instructions or a replacement.
The recalled product
- Product
- American Surgical Americot Blue 1/4" x 1/4" Ref Number: 20-01S Product Usage: Neurosurgical and Nonneurosurgical Sponges
- Manufacturer
- American Surgical Company
- Hazard
- Affected units
- 54
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)
- Lot number: 2015/09 AB 2015/12 BS 2015/12 BN 2016/01 AC
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 91 recalled by American Surgical Company under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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