Recall Z-1126-2022— TELEFLEX MEDICAL INC
Class II · Ongoing
Class II FDA medical device recall by TELEFLEX MEDICAL INC, initiated 2022-04-11. FDA's recall record names no specific 510(k) clearance for this event. Product: (1) Gibeck Humid-Vent 2S Flex DC, Product #17731, sterile; (2) Gibeck Humid-Vent 2S Flex DC, Product #17732, non-sterile; (3) Gibeck Humid-Vent Filter Compact S with Smooth-Flo/Swivel, Product #19061, sterile; (4) Gibeck Humid-Vent Filter Compact S with Smooth-Flo/Swivel, Product #19062, non-sterile; and (5) Gibeck Humid-Vent Filter Compact S with Flex Tube, Product #19812, non-sterile.. Reason: Reports received of torn corrugated breathing tubes..
- Recalling firm
- TELEFLEX MEDICAL INC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-04-11
- Firm location
- Morrisville, NC, United States
Product description
(1) Gibeck Humid-Vent 2S Flex DC, Product #17731, sterile; (2) Gibeck Humid-Vent 2S Flex DC, Product #17732, non-sterile; (3) Gibeck Humid-Vent Filter Compact S with Smooth-Flo/Swivel, Product #19061, sterile; (4) Gibeck Humid-Vent Filter Compact S with Smooth-Flo/Swivel, Product #19062, non-sterile; and (5) Gibeck Humid-Vent Filter Compact S with Flex Tube, Product #19812, non-sterile.
Reason for recall
Reports received of torn corrugated breathing tubes.
Data sourced from openFDA. This site is unofficial and independent of the FDA.