Ethicon Recalls Certain Proline Sutures Due to Packaging Design Issue
Ethicon is recalling specific Proline sutures because a packaging design issue allows the needle to perforate the package, posing a risk of injury or infection.
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 is classified as FDA Class II, and the source describes a risk of harm (soft tissue injury or infection) without reporting specific injuries or illnesses, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Ethicon, Inc. is recalling 2,844 units of PROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748. The recall is due to a packaging design issue where the needle associated with certain suture product codes has the potential to perforate the packaging.
A perforated package has the potential to cause a soft tissue injury to a healthcare professional handling the product. Additionally, a breach of sterility within the packaging could lead to a patient infection if the damage goes unnoticed by the healthcare professional.
The affected products were distributed to accounts in Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Massachusetts, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, New York, Ohio, Oregon, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin, and West Virginia. The specific lot codes involved are KDH853, KKH769, KLQ193, KPH698, LCH183, LCH570, LGB761, LJB020, LJH536, MCJ369, and MCJ447.
The recalled product
- Product
- PROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748
- Manufacturer
- Ethicon, Inc.
- Affected units
- 2,844
Distribution
Part of a larger recall action
This product is one of 19 recalled by Ethicon, Inc. 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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