Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506550
Summary
The FDA issued a Class I for Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506550 by TELEFLEX LLC. Reason: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products..
Details
Source
Device Recall
External ID
Z-1859-2023
Action Date
2023-07-05
Status
Ongoing
Category
device
Product Description
Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506550
Lot/Code Info: UDI/DI 4026704547715, Batch Numbers: 18FG01, 18FG05, 18FG13, 18GG17, 18GG31, 18HG12, 18HG19, 18JG21, 18JG32, 18KG41, 18LG18, 18LG28, 19AG21, 19DT25, 19DT33, 19ET54, 19ET77, 19FT24, 19GT59, 19GT65, 19HT24, 19HT61, 19IT29, 19JT42, 19JT49, 19JT57, 19KT25, 20AT14, 20AT25, 20AT44, 20BT05, 20BT27, 20BT37, 20BT51, 20CT05, 20CT12, 20CT36, 20DT09, 20ET56, 20GT06, 20GT38, KME20H1790, KME20J2114, KME20J3032, KME20K1344, KME20L1842, KME20L1843, KME20L2299, KME20M2094, KME20M2483, KME21A2812, KME21B1693, KME21C0020, KME22B1976, KME22H3204
Quantity Affected: 10600 units
Reason for Recall
Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
Distribution
US Nationwide distribution including Puerto Rico.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-05-25
Company
Morrisville, NC
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 367 device recalls issued in the same week, part of 413 device-related FDA actions this month.
TELEFLEX LLC has 139 FDA actions in our database, including 139 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (TELEFLEX LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does TELEFLEX LLC have FDA actions?
TELEFLEX LLC has 139 FDA actions in our database, including 139 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1859-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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