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.
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 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.
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