Ethicon Recalls Certain Prolene Sutures Due to Packaging Design Issue
Ethicon, Inc. is recalling specific Prolene suture products 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 involves a risk-of-harm product (potential soft tissue injury or infection) where no specific injuries or illnesses have been reported in the source text, fitting the criteria for a High severity score.
Plain-English summary
Ethicon, Inc. is recalling 3,024 units of PROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416. 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 subject product. Additionally, a breach of sterility within the packaging could lead to a patient infection if the perforation 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 KEH479, KHH259, KLH655, KMH715, LCH548, LHP422, LJJ896, and MAR884.
The recalled product
- Product
- PROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416
- Manufacturer
- Ethicon, Inc.
- Category
- Medical Device — Sutures
- Affected units
- 3,024
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)
- KEH479 KHH259 KLH655 KMH715 LCH548 LHP422 LJJ896 MAR884
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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