American Surgical Telfa Sponges Recalled for Packaging Sterility Defect
American Surgical Company is recalling Telfa sponges because defective packaging may compromise sterility. The affected lot is 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 medical device with a sterility defect, 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 7 boxes of Telfa 3/4" x 3" sponges (Ref Number: 80-11) used for neurosurgical and nonneurosurgical procedures. The recall is due to defective product packaging that compromises the sterility of the sponges.
The affected lot number is 2015/12 AP. The product was 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.
Consumers and healthcare facilities should stop using the affected sponges and contact American Surgical Company for further instructions.
The recalled product
- Product
- American Surgical Telfa 3/4" x 3" Ref Number: 80-11 Product Usage: Neurosurgical and Nonneurosurgical Sponges
- Manufacturer
- American Surgical Company
- Hazard
- Affected units
- 7
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: 2015/12 AP
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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