American Surgical Americot Sponges Recalled for Packaging Sterility Defect
American Surgical Company is recalling Americot White sponges because defective packaging may compromise sterility. The recall covers 35 boxes 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 is classified as FDA Class II. The hazard involves compromised sterility of surgical sponges, which poses a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.
Plain-English summary
American Surgical Company is recalling 35 boxes of Americot White 1.5 cm x 5.5 cm sponges (Ref Number: 20-31SW). These neurosurgical and nonneurosurgical sponges are being recalled because the product packaging is defective, which may compromise the sterility of the devices.
The affected lot numbers are 2015/11 AV and 2015/12 BC. 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 facilities and distributors should stop using the affected sponges and contact American Surgical Company for instructions on returning the product. Consumers should not use these medical devices if they have them in their possession.
The recalled product
- Product
- American Surgical Americot White 1.5 cm x 5.5 cm Ref Number: 20-31SW Product Usage: Neurosurgical and Nonneurosurgical Sponges
- Manufacturer
- American Surgical Company
- Affected units
- 35
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 numbers: 2015/11 AV 2015/12 BC
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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