Ethicon Recalls Certain Prolene Sutures Due to Packaging Design Issue
Ethicon, Inc. is recalling specific Prolene suture products because a packaging design issue allows the needle 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 is classified as FDA Class II. The source text describes potential for soft tissue injury and patient infection but does not report any actual illnesses or injuries, fitting the rubric criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Ethicon, Inc. is recalling 1,020 units of PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067. 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, if it goes unnoticed by the healthcare professional, has the potential to cause 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. The specific product codes involved are KKJ659, LAH044, LEH699, MCH331, MDH290, and MCQ536.
The recalled product
- Product
- PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067
- Manufacturer
- Ethicon, Inc.
- Category
- Medical Device — Sutures
- Affected units
- 1,020
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)
- KKJ659 LAH044 LEH699 MCH331 MDH290 MCQ536
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.
See all 19 products in this recall →Related recalls
Same manufacturer · Ethicon, Inc.
See all →- HighEthicon Recalls Monocryl Sutures Due to Component Mix-Up
FDA (Devices) · 2024-11-27
- HighCoated VICRYL Surgical Sutures Recalled for Needle Pull-Off and Degradation
FDA (Devices) · 2024-11-13
- HighPDS II Polydioxanone Sutures Recalled Due to Compromised Sterility
FDA (Devices) · 2024-06-26
- HighPDS Plus Antibacterial Surgical Sutures Recalled for Compromised Sterility
FDA (Devices) · 2024-06-26
- HighMONOCRYL Surgical Sutures Recalled for Packaging Sterility Defect
FDA (Devices) · 2024-06-26
Same hazard · soft tissue injury
See all →- HighMedical cot may experience unintended motion due to cable damage
FDA (Devices) · 2022-12-21
- HighMerit Medical Cultura Collection and Transport System Swab Tip Breakage Recall
FDA (Devices) · 2020-11-25
- HighMerit Medical Cultura Collection and Transport System recall due to swab tip breakage risk
FDA (Devices) · 2020-11-25
- HighEthicon Recalls PROXIMATE PPH Hemorrhoidal Circular Staplers Due to Missing Washer
FDA (Devices) · 2019-01-16
- HighEthicon Hemorrhoidal Circular Stapler Recalled for Missing Washer
FDA (Devices) · 2019-01-16