—#159472

Product

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

FDA product code: N/A
Affected lot / code info: Item number: DYNJ0165296D. Lots: 16CK2326; 16DK0985; 16DK2816; 16GK2433; 16IK0634; 16KK0117; 17AK1788; 17BK2514

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Firm contacted customers via phone and letter beginning April 12, 2017. Customers were instructed to remove the Ethicon BioPatch Protective Disk with CHG from the kit(s) and return it to the firm. The firm would provide a sterile replacement BioPatch. Affected product will be destroyed.

Recalling firm

Firm: Medline Industries, Inc.
Address: 1170 S Northpoint Blvd, Waukegan, Illinois 60085-6757

Distribution

Distribution pattern: CA, NM

Timeline

Recall initiated: 2017-04-12
Terminated: 2019-08-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #159472. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.