Recall Z-2464-2018— Ethicon, Inc.

Name: FDA recall Z-2464-2018
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: PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631. 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

PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631

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.