Reported Sep 12, 2018 · Terminated
PICC Tray, STERILE, 12 packs each per case.
Medline Industries, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medline Industries, Inc. · 1170 S Northpoint Blvd · Waukegan, IL · 60085-6757
Is this the product you have?
- PICC Tray, STERILE, 12 packs each per case.
- Lot codes and dates
- Item numberDYNJ49177C
- Lots
16HB470016UB507617MB6837
- Amount recalled
- 144 kits
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
Why it 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.
This product could cause temporary or reversible health problems — stop using it.
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