Ethicon Recalls Prolene Sutures Due to Packaging Perforation Risk
Ethicon is recalling specific Prolene suture units because a packaging design issue allows needles to perforate the package, posing injury and infection risks.
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 and infection) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Ethicon, Inc. is recalling 552 units of PROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688. 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 or a patient infection due to a breach of sterility if the damage goes unnoticed. The affected units 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.
Healthcare professionals should stop using the affected suture units and contact Ethicon for further instructions. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- Product
- PROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688
- Manufacturer
- Ethicon, Inc.
- Category
- Medical Device — Sutures
- Affected units
- 552
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)
- LCB888 LCH204
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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