Reported Jun 1, 2016 · Terminated
American Surgical Delicot 5 mm x 8 mm Ref Number: 63-01 Product Usage: Neurosurgical and Nonneurosurgical Sponges
American Surgical Company
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: American Surgical Company · 45 Congress St · Salem, MA · 01970-5579
Is this the product you have?
- American
- Surgical Delicot 5 mm x 8 mm Ref Number63-01
- Product UsageNeurosurgical and Nonneurosurgical Sponges
- Lot codes and dates
- Lot numbers2015/08 CF 2015/09 CI 2015/10 CM 2015/11 AH 2015/10 CA 2015/11 AM 2015/11 BO 2015/12 AL 2015/11 BS 2015/11 BV 2015/11 BY 2015/12 AT 2015/12 BF 2015/12 CA
- Amount recalled
- 287 boxes
This recall covers 91 products
The agency filed one notice per product. You are reading one of them; the other 90 are below.
78 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
Product packaging defective compromising sterility
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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