Recall Z-0147-2025— Smiths Medical ASD Inc.
Class II · Ongoing
Class II FDA medical device recall by Smiths Medical ASD Inc., initiated 2024-07-18. FDA's recall record names no specific 510(k) clearance for this event. Product: smiths medical portex, Thermovent 1200, 15mm/22mm: a) REF 100/582/000; b) REF 100/582/000JP; c) REF 100/582/000JS. Reason: Uncertainty in the seal integrity of the sterile packaging..
- Recalling firm
- Smiths Medical ASD Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-07-18
- Firm location
- Minneapolis, MN, United States
Product description
smiths medical portex, Thermovent 1200, 15mm/22mm: a) REF 100/582/000; b) REF 100/582/000JP; c) REF 100/582/000JS
Reason for recall
Uncertainty in the seal integrity of the sterile packaging.
Data sourced from openFDA. This site is unofficial and independent of the FDA.