Z-2976-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- September 12, 2018
- Initiation Date
- April 12, 2017
- Termination Date
- August 5, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,000 kits
Product Description
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 Pattern
CA, NM
Code Information
Item number: DYNJ0165296D. Lots: 16CK2326; 16DK0985; 16DK2816; 16GK2433; 16IK0634; 16KK0117; 17AK1788; 17BK2514