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Medline Industries, Inc. recalls Art-Line Surgery Pack-LF, STERILE, 40 packs each per case.
Recalled September 12, 2018 · FDA recall Z-2976-2018 · Medline Industries
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. · FDA Class II
Units
3,000 kits
Sold at
CA, NM
Description
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.
Product
Art-Line Surgery Pack-LF, STERILE, 40 packs each per case.
Manufacturer(s)
Medline Industries, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →