Ethicon Recalls Certain Prolene Sutures Due to Packaging Design Issue
Ethicon is recalling specific Prolene suture products because a packaging design issue allows needles 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 the source text describes the potential for harm but does not report any actual injuries or illnesses.
Plain-English summary
Ethicon, Inc. is recalling 4,452 units of PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988. 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 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 KEB377, KEH280, KGP662, KMJ048, KPP500, LCH042, LHP301, LJE786, LPB869, MAH170, MCH330, and MCQ992. Healthcare professionals should check their inventory for these specific product codes and stop using the affected units.
The recalled product
- Product
- PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988
- Manufacturer
- Ethicon, Inc.
- Category
- Medical Device — Sutures
- Affected units
- 4,452
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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