Ethicon Recalls Proline Sutures Due to Packaging Perforation Risk
Ethicon is recalling specific Proline suture products because a packaging design issue allows needles to perforate the package, posing injury and 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 and infection) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Ethicon, Inc. is recalling 1,752 units of PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031. The recall affects accounts in Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Massachusetts, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, New York, Ohio, Oregon, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin, and West Virginia.
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. If a package is perforated and the breach goes unnoticed by a healthcare professional, it can cause soft tissue injury to the professional handling the product or lead to patient infection due to a breach of sterility.
Healthcare professionals should check their inventory for the affected product codes (KDJ805, KDP827, LBB354, MAP602) and stop using any units that may be affected. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- Product
- PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031
- Manufacturer
- Ethicon, Inc.
- Category
- Medical Device — Sutures
- Affected units
- 1,752
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)
- KDJ805 KDP827 LBB354 MAP602
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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