smiths medical portex, Thermovent 1200, 15mm/22mm: a) REF 100/582/000; b) REF 100/582/000JP; c) REF 100/582/000JS
Reported: October 30, 2024 Initiated: July 18, 2024 #Z-0147-2025
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.
Details
- Recalling Firm
- Smiths Medical ASD Inc.
- Units Affected
- 141,196 units
- Distribution
- Worldwide distribution.
- Location
- Minneapolis, MN
Frequently Asked Questions
What product was recalled? ▼
smiths medical portex, Thermovent 1200, 15mm/22mm: a) REF 100/582/000; b) REF 100/582/000JP; c) REF 100/582/000JS. Recalled by Smiths Medical ASD Inc.. Units affected: 141,196 units.
Why was this product recalled? ▼
Uncertainty in the seal integrity of the sterile packaging.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 30, 2024. Severity: Moderate. Recall number: Z-0147-2025.
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