FDA (Devices) recall action 80306
The FDA (Devices) publishes a recall like this one as 19 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 19 pages.
The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue injury to a healthcare professional handling the subject product or a patient infection due to a breach of sterility within the packaging if it goes unnoticed by the healthcare professional.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Ethicon is recalling specific Proline suture products because a packaging design issue allows needles to perforate the package, posing injury and infection risks.
Ethicon is recalling 372 units of Proline Suture Blue 18" 7-0 because the needle may perforate the packaging, posing a risk of soft tissue injury or infection.
Ethicon is recalling 1,728 units of Proline suture because a packaging design issue allows needles to perforate the package, posing injury and infection risks.
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.
Ethicon is recalling specific Prolene suture units because a packaging design issue allows needles to perforate the package, posing injury and infection risks.
Ethicon is recalling 516 units of Pronova Suture Blue because the needle may perforate the packaging, posing a risk of soft tissue injury or infection.
Ethicon is recalling specific Prolene suture products because a packaging design issue may allow needles to perforate the package, posing injury and infection risks.
Ethicon is recalling specific Proline sutures because the needle may perforate the packaging, posing a risk of soft tissue injury or infection.
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.
Ethicon is recalling specific PRONOVA suture needles because a packaging design issue may allow the needle to perforate the package, posing injury or infection risks.
Ethicon is recalling specific Proline suture products because the needle may perforate the packaging, posing a risk of soft tissue injury or infection.
Ethicon is recalling specific Proline sutures because a packaging design issue allows needles to perforate the package, posing injury and infection risks.
Ethicon, Inc. is recalling 432 units of Prolene Suture 30" 8-0 Blue (D8292) because the needle may perforate the packaging, posing a risk of injury or infection.
Ethicon is recalling specific Prolene suture products because a packaging design issue may allow needles to perforate the package, posing injury and infection risks.
Ethicon is recalling specific Prolene suture products because a packaging design issue allows needles to perforate the package, posing a risk of injury or infection.
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.
Ethicon is recalling specific Proline sutures because a packaging design issue allows the needle to perforate the package, posing a risk of injury or infection.
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.
Ethicon is recalling 588 units of Proline Suture Blue 4x18" 5/0 due to a packaging design issue that may allow the needle to perforate the package, posing a risk of injury or infection.