American Surgical Uniqcot Sponges Recalled for Packaging Defect Compromising Sterility
American Surgical Company is recalling Uniqcot sponges because defective packaging may compromise sterility. The recall covers 3 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 and involves a risk-of-harm product (sterility compromise) where injury has not yet been reported, meeting the criteria for a High severity score.
Plain-English summary
American Surgical Company is recalling 3 boxes of Uniqcot 1/2" x 2" sponges (Ref Number: 67-29) due to a packaging defect that compromises sterility. These neurosurgical and nonneurosurgical sponges were distributed worldwide, including in the United States, 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.
The affected lot number is 2015/09 BG. The recall is classified as Class II by the U.S. Food and Drug Administration. The source text does not report any illnesses or injuries associated with this recall.
Healthcare facilities and consumers should stop using the affected sponges and contact American Surgical Company for instructions on return or replacement.
The recalled product
- Product
- American Surgical Uniqcot 1/2" x 2" Ref Number: 67-29 Product Usage: Neurosurgical and Nonneurosurgical Sponges
- Manufacturer
- American Surgical Company
- Affected units
- 3
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: 2015/09 BG
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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