Recall Z-2466-2018— Ethicon, Inc.

Name: FDA recall Z-2466-2018
Creator: U.S. Food and Drug Administration
Published: 2018-05-07

Class II · Terminated

Class II FDA medical device recall by Ethicon, Inc., initiated 2018-05-07, terminated 2020-06-08. It names one FDA 510(k) clearance: K133356. Product: PRONOVA SUTURE BLUE 122CM M1.5, D10189. Reason: 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..

Recalling firm: Ethicon, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-05-07
Terminated: 2020-06-08
Firm location: Somerville, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K133356 — PROLENE POLYPROPYLENE NONABSORBABLE SUTUREETHICON, Inc.·cleared 2013-12-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

PRONOVA SUTURE BLUE 122CM M1.5, D10189

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.