Recall Z-1177-2023— Covidien, LP

Name: FDA recall Z-1177-2023
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: K955747. Product: Surgidac Uncoated Braided Polyester suture Product Description D-1764K SURGIDAC* 5-0 WHI 45CM SS24DA. 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

K955747 — USSC NONABSORBABLE SUTURESUnited 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

Surgidac Uncoated Braided Polyester suture Product Description D-1764K SURGIDAC* 5-0 WHI 45CM SS24DA

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.