Recall Z-1126-2022 ยท BYD Condenser, Heat And Moisture (Artificial Nose)
TELEFLEX MEDICAL INC
(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.
| Date | Apr 11, 2022 |
| Status | Open, Classified |
| Reason | Reports received of torn corrugated breathing tubes. |
| Root cause | Device Design |
| Action | The recalling firm issued letters dated April 2022 on 4/11/2022 via FedEx 2-day mail. The letter described the issue, the immediate actions required including the hazards involved, and provided specific actions to be taken and instructions to be followed by the medical facilities or the distributors. For the medical facilities, they are to cease use and distribution of the impacted product and immediately quarantine it. If the product is in inventory, indicate the information on the Acknowledgment Form and FAX it to Customer Service or email it to the firm. A customer service representati |
| Quantity | 59,581 eaches |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NV, NY, OH, PA, SC, TN, TX, UT, VA, WA, WI, and WV. The countries of Austria, Australia, Belgium, Canada, Chile, Czech Republic, Finland, F |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.