Iso-Gard Filter S, REF : a) 19211, OUS only; b) 19212; Microbial medical gas filter, single-use. Bacterial/viral filters for use in breathing system for the protection of patient and equipment.
Reported: October 26, 2022 Initiated: August 29, 2022 #Z-0072-2023
Product Description
Iso-Gard Filter S, REF : a) 19211, OUS only; b) 19212; Microbial medical gas filter, single-use. Bacterial/viral filters for use in breathing system for the protection of patient and equipment.
Reason for Recall
Incidents of device splitting or detaching during use
Details
- Recalling Firm
- TELEFLEX LLC
- Units Affected
- 60,500 units US
- Distribution
- US nationwide distribution
- Location
- Morrisville, NC
Frequently Asked Questions
What product was recalled? ▼
Iso-Gard Filter S, REF : a) 19211, OUS only; b) 19212; Microbial medical gas filter, single-use. Bacterial/viral filters for use in breathing system for the protection of patient and equipment.. Recalled by TELEFLEX LLC. Units affected: 60,500 units US.
Why was this product recalled? ▼
Incidents of device splitting or detaching during use
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 26, 2022. Severity: Critical. Recall number: Z-0072-2023.
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