RUSCH Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF numbers: a) 112080050 b) 112080055 c)
Summary
The FDA issued a Class II for RUSCH Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF n by Teleflex Medical Europe Ltd. Reason: The firm received reports that the endotracheal tube cuff could be inflated while the pilot balloon remained flat..
Details
Source
Device Recall
External ID
Z-2321-2021
Action Date
2021-08-25
Status
Completed
Category
device
Product Description
RUSCH Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF numbers: a) 112080050 b) 112080055 c) 112080060 d) 112080065 e) 112080070 f) 112080075 g) 112080080 h) 112080085 i) 112080090 j) 112080095 k) 112080100
Lot/Code Info: a) 112080050, Lot Numbers: KME20K1512, KME20L1145, KME20M2383, KME21B0357 b) 112080055, Lot Numbers: KME20K2579, KME21A2569, KME21C1978 c) 112080060, Lot Numbers: KME20M0616, KME20M2112, KME21A2685 d) 112080065, Lot Numbers: KME20K2581, KME21C1701 e) 112080070, Lot Numbers: KME20K2577, KME20L1985, KME20M1771, KME20M1772, KME20M2856, KME21A2355, KME21B1624, KME21B2490, KME21C1184 f) 112080075, Lot Numbers: KME20K0110 g) 112080080, Lot Numbers: KME20M0377, KME21B2727, KME21C0500 h) 112080085, Lot Numbers: KME20M0909, KME21B0519, KME21C0067 i) 112080090, Lot Numbers: KME20K1808, KME20L2352, KME20M2248 j) 112080095, Lot Numbers: KME20K2310, KME20L1153 k) 112080100 Lot Numbers: KME20K1005, KME20L1144
Quantity Affected: 2610 units
Reason for Recall
The firm received reports that the endotracheal tube cuff could be inflated while the pilot balloon remained flat.
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-07-16
Company
Athlone, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 221 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Teleflex Medical Europe Ltd has 4 FDA actions in our database, including 4 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
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 Medical Europe Ltd) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Teleflex Medical Europe Ltd have FDA actions?
Teleflex Medical Europe Ltd has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2321-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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