Recall Z-1173-2023— Covidien, LP

Name: FDA recall Z-1173-2023
Creator: U.S. Food and Drug Administration
Published: 2022-12-02

Class II · Ongoing

Class II FDA medical device recall by Covidien, LP, initiated 2022-12-02. It names one FDA 510(k) clearance: K900531. Product: Monofilament Nylon Suture (McKesson Branded) and Coated Braided Silk Suture (McKesson Branded) (1) S661GX 5-0 NYLON 18 DS18 (2)S683GX 4-0 SILK 18 DS18 (3) S683GX 4-0 SILK 18 DS18 (4)S697GX 6-0 NYLON 18 DSM11 (5)S697GX 6-0 NYLON 18 DSM11 (6)S913BX 5-0 NYLON 10 DS12 (7)S931BX 4-0 NYLON 10 DS12. Reason: Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact.

Recalling firm: Covidien, LP
Classification: Class II
Status: Ongoing
Initiated: 2022-12-02
Firm location: North Haven, CT, United States

510(k) clearances named in this recall

1 on FDA's record

K900531 — NONABSORBABLE NYLON SURGICAL SUTURE*United States Surgical, A Division of Tyco Healthc·cleared 1990-07-05

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

Monofilament Nylon Suture (McKesson Branded) and Coated Braided Silk Suture (McKesson Branded) (1) S661GX 5-0 NYLON 18 DS18 (2)S683GX 4-0 SILK 18 DS18 (3) S683GX 4-0 SILK 18 DS18 (4)S697GX 6-0 NYLON 18 DSM11 (5)S697GX 6-0 NYLON 18 DSM11 (6)S913BX 5-0 NYLON 10 DS12 (7)S931BX 4-0 NYLON 10 DS12

Reason for recall

Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact

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