Art-Line Surgery Pack-LF — Class II medical device recall Z-2976-2018
Terminated recall by Medline Industries, Inc., reported 2018-09-12, distributed in CA, NM. Multiple surgical packs were assembled with a non-sterile CHG disk labeled as BIOPATCH" (kit component #52655
| Recall number | Z-2976-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medline Industries, Inc., Waukegan, IL, United States |
| Recall initiated | 2017-04-12 |
| Classified | 2018-09-06 |
| Reported by FDA | 2018-09-12 |
| Terminated | 2019-08-05 |
| Distributed | CA, NM |
| Quantity | 3,000 kits |
| Reason classes | microbial contamination, labeling, sterility |
| Lot numbers | 16CK2326, 16DK0985, 16DK2816, 16GK2433, 16IK0634, 16KK0117, 17AK1788, 17BK2514 |
| Model numbers | 16CK2326, DYNJ0165296D |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2976-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.