American Surgical Delicot Sponges Recalled for Packaging Defect Compromising Sterility
American Surgical Company is recalling 113 boxes of Delicot 6 mm x 50 mm sponges because defective packaging may compromise sterility.
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 injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
American Surgical Company is recalling 113 boxes of American Surgical Delicot 6 mm x 50 mm sponges, Reference Number 63-06. These neurosurgical and nonneurosurgical sponges are being recalled because defective product packaging may compromise sterility.
The affected product includes lot numbers 2015/09 BC and 2015/11 BB. The 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.
Healthcare facilities and consumers should stop using the affected sponges and contact American Surgical Company for further instructions.
The recalled product
- Product
- American Surgical Delicot 6 mm x 50 mm Ref Number: 63-06 Product Usage: Neurosurgical and Nonneurosurgical Sponges
- Manufacturer
- American Surgical Company
- Hazard
- Affected units
- 113
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 BC 2015/11 BB
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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