Ethicon Recalls Proline Sutures Due to Packaging Perforation Risk
Ethicon is recalling 300 units of Proline Suture 30" 6-0 Blue because a packaging design issue may allow the needle to perforate the package, posing injury or 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, aligning with the 'High' severity criteria for theoretical risks.
Plain-English summary
Ethicon, Inc. is recalling 300 units of PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647. The recall is due to a packaging design issue where the needle associated with the suture has the potential to perforate the packaging.
A perforated package may cause soft tissue injury to a healthcare professional handling the product or patient infection due to a breach of sterility if the damage goes unnoticed. 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.
Healthcare professionals should check their inventory for the specific product code D8647 and lot codes LEH169 or MCH333. If the product is found, it should be removed from use and returned to Ethicon, Inc. per the recall instructions.
The recalled product
- Product
- PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647
- Manufacturer
- Ethicon, Inc.
- Affected units
- 300
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)
- LEH169 MCH333
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