PICC Tray, STERILE, 12 packs each per case.
Reported: September 12, 2018 Initiated: April 12, 2017 #Z-2977-2018
Product Description
PICC Tray, STERILE, 12 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.
Details
- Recalling Firm
- Medline Industries, Inc.
- Units Affected
- 144 kits
- Distribution
- CA, NM
- Location
- Waukegan, IL
Frequently Asked Questions
What product was recalled? ▼
PICC Tray, STERILE, 12 packs each per case.. Recalled by Medline Industries, Inc.. Units affected: 144 kits.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 12, 2018. Severity: Moderate. Recall number: Z-2977-2018.
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