Recall Z-2977-2018— Medline Industries, Inc.
Class II · Terminated
Class II FDA medical device recall by Medline Industries, Inc., initiated 2017-04-12, terminated 2019-08-05. FDA's recall record names no specific 510(k) clearance for this event. Product: PICC Tray, STERILE, 12 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..
- Recalling firm
- Medline Industries, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-04-12
- Terminated
- 2019-08-05
- Firm location
- Waukegan, IL, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.