Ethicon Recalls Proline Sutures Due to Packaging Perforation Risk
Ethicon is recalling specific Proline suture products because the needle may perforate the packaging, posing a risk of soft tissue 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 involves a risk of harm (soft tissue injury or infection) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Ethicon, Inc. is recalling 276 units of PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995. The recall is due to a packaging design issue where the needle associated with the suture has the potential to perforate the packaging.
The FDA classifies this as a Class II recall. A perforated package could cause a soft tissue injury to a healthcare professional handling the product or lead to a patient infection if the breach of sterility goes unnoticed.
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. Healthcare professionals should stop using the affected products and contact Ethicon for instructions.
The recalled product
- Product
- PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995
- Manufacturer
- Ethicon, Inc.
- Affected units
- 276
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)
- KJQ124
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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