PlainRecalls
FDA Devices Moderate Class II Ongoing

PICC KIT, 10/CS, ACCESS MEDICAL LABEL

Reported: January 18, 2023 Initiated: December 15, 2022 #Z-0935-2023

Product Description

PICC KIT, 10/CS, ACCESS MEDICAL LABEL

Reason for Recall

Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.

Details

Recalling Firm
Stradis Healthcare
Units Affected
180 units
Distribution
US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.
Location
Waukegan, IL

Frequently Asked Questions

What product was recalled?
PICC KIT, 10/CS, ACCESS MEDICAL LABEL. Recalled by Stradis Healthcare. Units affected: 180 units.
Why was this product recalled?
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
Which agency issued this recall?
This recall was issued by the FDA Devices on January 18, 2023. Severity: Moderate. Recall number: Z-0935-2023.