Recall Z-1340-2018— Ethicon, Inc.

Name: FDA recall Z-1340-2018
Creator: U.S. Food and Drug Administration
Published: 2018-01-10

Class II · Terminated

Class II FDA medical device recall by Ethicon, Inc., initiated 2018-01-10, terminated 2019-04-11. It names one FDA 510(k) clearance: K061037. Product: PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Single Armed CTB-1 Needle. Reason: Three (3) lots were distributed with the incorrect expiry date on the label. The lots were labeled with an expiry date of five (5) years from date of manufacture instead of the correct expiry date of two (2) years from date of manufacture..

Recalling firm: Ethicon, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-01-10
Terminated: 2019-04-11
Firm location: Somerville, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K061037 — PDS PLUS ANTIBACTERIAL SUTUREETHICON, Inc.·cleared 2006-07-14

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

PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Single Armed CTB-1 Needle

Reason for recall

Three (3) lots were distributed with the incorrect expiry date on the label. The lots were labeled with an expiry date of five (5) years from date of manufacture instead of the correct expiry date of two (2) years from date of manufacture.

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