FDA Device recall Z-2976-2018
Art-Line Surgery Pack-LF, STERILE, 40 packs each per case
- FDA Device
- Class II
- terminated
- Published 2018-09-12
On 2018-09-12 the FDA classified a Class II recall of Art-Line Surgery Pack-LF, STERILE, 40 packs each per case by Medline Industries, citing 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 potentia….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2976-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-04-12 |
| Published | 2018-09-12 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Medline Industries |
| Distribution | CA, NM |
Product
Art-Line Surgery Pack-LF, STERILE, 40 packs each per case.
Reason
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.
Identifiers
| code_info | Item number: DYNJ0165296D. Lots: 16CK2326; 16DK0985; 16DK2816; 16GK2433; 16IK0634; 16KK0117; 17AK1788; 17BK2514 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2976-2018%22
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