Recall Z-0935-2023— Stradis Healthcare
Class II · Ongoing
Class II FDA medical device recall by Stradis Healthcare, initiated 2022-12-15. FDA's recall record names no specific 510(k) clearance for this event. Product: PICC KIT, 10/CS, ACCESS MEDICAL LABEL. Reason: Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit..
- Recalling firm
- Stradis Healthcare
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-12-15
- Firm location
- Waukegan, IL, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.