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U.S. Department of Health and Human Services

Class 2 Device Recall RUSCH Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff

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 Class 2 Device Recall RUSCH Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuffsee related information
Date Initiated by FirmJuly 16, 2021
Create DateAugust 19, 2021
Recall Status1 Open3, Classified
Recall NumberZ-2321-2021
Recall Event ID 88353
510(K)NumberK961837 
Product Classification Tube, tracheal (w/wo connector) - Product Code BTR
ProductRUSCH 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
Code Information 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
FEI Number 3007134520
Recalling Firm/
Manufacturer		 Teleflex Medical Europe Ltd
Ida Business Park
Athlone Ireland
For Additional Information Contact
3530877519577
Manufacturer Reason
for Recall		The firm received reports that the endotracheal tube cuff could be inflated while the pilot balloon remained flat.
FDA Determined
Cause 2		Process control
ActionThe firm initiated the recall by letter on 07/16/2021. The letter explained the issue and requested the return of the product. Distributors were directed to notify their customers.
Quantity in Commerce2610 units
DistributionUS Nationwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = BTR
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