Art-Line Surgery Pack-LF recall: Sterility Concern
Art-Line Surgery Pack-LF, STERILE, 40 packs each per case.
Why was Art-Line Surgery Pack-LF 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Item number: DYNJ0165296D. Lots: 16CK2326; 16DK0985; 16DK2816; 16GK2433; 16IK0634; 16KK0117; 17AK1788; 17BK2514
- Product
- Art-Line Surgery Pack-LF, STERILE, 40 packs each per case.
- Recalling firm
- Medline Industries, Inc.
- Quantity
- 3,000 kits
- Distribution
- CA, NM
- Recall date
- September 12, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)