Ethicon Recalls Certain Prolene Sutures Due to Packaging Perforation Risk
Ethicon is recalling specific Prolene suture products because a packaging design issue may allow 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 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 4,440 units of PROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746. 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 or a patient infection due to a breach of sterility within the packaging if it goes unnoticed by the healthcare professional.
The affected products were distributed to accounts in AZ, CA, CO, FL, GA, IL, IN, KS, MA, MN, MO, NC, NE, NJ, NY, OH, OR, SC, SD, TN, TX, VA, WA, WI, and WV. The specific lot codes involved are KDH782, KEH344, KEJ158, KGJ668, KGQ354, KJE929, KJH424, KKJ658, LAB267, LCH376, LCH571, LEB803, LGB860, LKR893, LPJ096, LPP510, MCJ449, and MCQ993.
The recalled product
- Product
- PROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746
- Manufacturer
- Ethicon, Inc.
- Category
- Medical Device — Sutures
- Affected units
- 4,440
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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