Recall Z-1179-2023— Covidien, LP

Name: FDA recall Z-1179-2023
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: K954808. Product: Surgipro Monofilament Polypropylene Sutures Product Description CP-535 SURGIPRO* 1 BLU 100CM GS24 X36 CP-824 SURGIPRO* 1 BLU 150CM GS26 X24 CP-825 SURGIPRO* 2 BLU 150CM GS26 X24 VP-543 SURGIPRO* 2-0 BLU 120CM V20 DA. 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

K954808 — USSC POLYPROPLENE SUTUREUnited States Surgical, A Division of Tyco Healthc·cleared 1996-02-27

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

Surgipro Monofilament Polypropylene Sutures Product Description CP-535 SURGIPRO* 1 BLU 100CM GS24 X36 CP-824 SURGIPRO* 1 BLU 150CM GS26 X24 CP-825 SURGIPRO* 2 BLU 150CM GS26 X24 VP-543 SURGIPRO* 2-0 BLU 120CM V20 DA

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.