American Surgical Delicot-J Sponges Recalled for Sterility Compromise
American Surgical Company is recalling 68 boxes of Delicot-J sponges because defective packaging compromises sterility. The products were 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 hazard is compromised sterility, but no injuries or illnesses have been reported in the source text.
Plain-English summary
American Surgical Company is recalling 68 boxes of Delicot-J 15 mm x 20 mm sponges (Ref Number: 63-04J). These neurosurgical and nonneurosurgical sponges are subject to recall because defective product packaging compromises sterility.
The affected lot number is 2016/01 AQ. The products were distributed worldwide, including 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.
Consumers and healthcare facilities should stop using the recalled sponges and contact American Surgical Company for instructions on return or replacement.
The recalled product
- Product
- American Surgical Delicot-J 15 mm x 20 mm Ref Number: 63-04J (Japan Only) Product Usage: Neurosurgical and Nonneurosurgical Sponges
- Manufacturer
- American Surgical Company
- Hazard
- Affected units
- 68
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: 2016/01 AQ
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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