Recall Z-0015-2019— COVIDIEN LLC

Name: FDA recall Z-0015-2019
Creator: U.S. Food and Drug Administration
Published: 2018-08-01

Class II · Terminated

Class II FDA medical device recall by COVIDIEN LLC, initiated 2018-08-01, terminated 2020-06-03. It names one FDA 510(k) clearance: K990530. Product: Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.. Reason: Potential for product sterility breach due to a compromised or pinched seal defect.

Recalling firm: COVIDIEN LLC
Classification: Class II
Status: Terminated
Initiated: 2018-08-01
Terminated: 2020-06-03
Firm location: Mansfield, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K990530 — KERLIX MD ANTIMICROBIAL GAUZE DRESSINGThe Kendall Company, L.P.·cleared 2000-01-31

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

Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

Reason for recall

Potential for product sterility breach due to a compromised or pinched seal defect

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