Reported Mar 7, 2018 · Terminated
ProLite Mesh - mesh, surgical, polymeric ProLite Mesh is intended for use in soft tissue deficiencies including hernia…
Atrium Medical Corporation
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: Atrium Medical Corporation · 40 Continental Blvd · Merrimack, NH · 03054-4332
Is this the product you have?
- ProLite Mesh - mesh, surgical, polymeric ProLite Mesh is intended for use in soft tissue deficiencies including hernia repair, traumatic or surgical wounds and chest wall reconstruction procedures requiring reinforcement with a non-absorbable supportive material.
- Lot codes and dates
- Product
- Code/REF 1010306-06 Lot Number/LOT412298
- Amount recalled
- 60 units
Why it was recalled
An incorrect ProLite Mesh configuration was packaged as product code 1010306-06, with lot number 412298. ProLite Mesh manufactured as product code 1010306-04 was inadvertently placed inside the pouch of packages labeled with product code 1010306-06 and lot number 412298.
This product could cause temporary or reversible health problems — stop using it.
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