FDA-Device2018-09-12Class II
Art-Line Surgery Pack-LF, STERILE, 40 packs each per case.
Medline Industries, Inc.
Hazard
Multiple surgical packs were assembled with a non-sterile CHG disk labeled as BIOPATCH" (kit component #52655) attached to the outside of the sterile pack. This may pose potential risk of infection. However, the kits have been in distribution since March 2016. Many of these kits have been used with no reported infections or adverse patient events. In addition, the BIOPATCH is impregnated with CHG, a well-known antiseptic agent with broad-spectrum anti-microbial and antifungal activity.
Sold states
CA, NM
Affected count
3,000 kits
Manufactured in
1170 S Northpoint Blvd, N/A, Waukegan, IL, United States
Products
Art-Line Surgery Pack-LF, STERILE, 40 packs each per case.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2976-2018Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief