American Surgical Delicot X Sponges Recalled for Packaging Sterility Defect
American Surgical Company is recalling Delicot X sponges due to packaging defects that compromise sterility. The recall covers 3 boxes distributed worldwide.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or structural defects are rated Severe (4). Compromised sterility in surgical sponges poses a significant risk of infection.
Plain-English summary
American Surgical Company is recalling 3 boxes of Delicot X 6 mm x 50 mm sponges (Ref Number: 63x06). These neurosurgical and nonneurosurgical sponges are being recalled because the product packaging is defective, which compromises the sterility of the devices.
The affected lot number is 2015/10 CG. 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.
The FDA has classified this as a Class II recall. Consumers and healthcare providers should stop using the affected sponges and contact American Surgical Company for further instructions.
The recalled product
- Product
- American Surgical Delicot X 6 mm x 50 mm Ref Number: 63x06 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: 2015/10 CG
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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