Recall Z-0013-2019— COVIDIEN LLC

Name: FDA recall Z-0013-2019
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 AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.. 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 AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.

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.