FDA recall Z-2976-2018

Product

Art-Line Surgery Pack-LF, STERILE, 40 packs each per case.

Reason for recall

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.

Distribution

CA, NM

Key facts

Status

Terminated

Initiation date

2017-04-12

Report date

2018-09-12

Termination date

2019-08-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Waukegan, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2976-2018