Ethicon Recalls Certain Prolene Sutures Due to Packaging Perforation Risk
Ethicon is recalling specific Prolene suture products because a packaging design issue allows needles to perforate the package, posing risks of soft tissue injury or infection.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 the source describes potential for soft tissue injury and patient infection without reporting specific confirmed illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Ethicon, Inc. is recalling 4,968 units of PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844. 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, if the perforation goes unnoticed, a breach of sterility within the packaging could lead to a patient infection.
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. Specific lot codes involved include KDQ180, KJH311, KKH758, KMP871, KPH811, LAH127, LAH648, LDP694, LHB945, LJE966, LMJ318, LMR835, MAH349, MBE216, MCQ994, MCQ537, and MCQ538. Healthcare professionals should check their inventory for these specific product codes and discontinue use if found.
The recalled product
- Product
- PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844
- Manufacturer
- Ethicon, Inc.
- Category
- Medical Device — Sutures
- Affected units
- 4,968
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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