Recall record at a glance
| Official record | Z-2976-2018 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Medline Industries, Inc. |
| Report date | Sep 12, 2018 |
| Recall initiation date | Apr 12, 2017 |
| Quantity | 3,000 kits |
| Location | Waukegan, IL, United States |
Official product description
Art-Line Surgery Pack-LF, STERILE, 40 packs each per case.
Why the product was 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.
Distribution information
CA, NM
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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