Art-Line Surgery Pack-LF, STERILE, 40 packs each per case.
- Company
- Medline Industries, Inc.
- Recall Initiated
- April 12, 2017
- Terminated
- August 5, 2019
- Recall Number
- Z-2976-2018
- Quantity
- 3,000 kits
- Firm Location
- Waukegan, IL
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
Lot / Code Info
Item number: DYNJ0165296D. Lots: 16CK2326; 16DK0985; 16DK2816; 16GK2433; 16IK0634; 16KK0117; 17AK1788; 17BK2514
Root Cause
Under Investigation by firm
Action Taken
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.