| Date Initiated by Firm |
December 13, 2019 |
| Date Posted |
February 07, 2020 |
| Recall Status1 |
Terminated 3 on April 30, 2024 |
| Recall Number |
Z-1114-2020 |
| Recall Event ID |
84588 |
| 510(K)Number |
K131912
|
| Product Classification |
Humidifier, respiratory gas, (direct patient interface) - Product Code BTT
|
| Product |
HUDSON RCI COMFORT FLO Humidification System, REF 2410, humidifier nebulizer kit |
| Code Information |
GTIN 14026704659347 Lot Numbers: 74M1400306 74M1400711 74M1401528 74B1500017 74C1501165 74C1502056 74D1500014 74D1500695 74D1501704 74D1501219 74D1501910 74E1500306 74E1501372 74E1501373 74E1501374 74E1501375 74E1501371 74M1500846 74M1501089 74A1600595 74A1601230 74B1600045 74C1601038 74C1601644 74C1602406 74C1601594 74C1602113 74C1602114 74C1602115 74C1602116 74C1602117 74C1602146 74D1600254 74D1600253 74D1601801 74E1600052 74E1601253 74F1600669 74F1603321 74G1600071 74G1601038 74H1600051 74H1600052 74H1603043 74J1601205 74J1601478 74J1602063 74J1602658 74J1602865 74J1602864 74K1602260 74K1602874 74L1600133 74L1601767 74L1602602 74M1600527 74M1601523 74A1700288 74A1700995 74A1701895 74B1701971 74B1702316 74C1701847 74D1700109 74D1701791 74E1700933 74E1702182 74E1702251 74F1700030 74F1702959 74G1700802 74H1700006 74H1700404 74J1700408 74J1701883 74J1701884 74K1700025 74K1700305 74L1700955 74L1701845 74M1700483 74A1801553 74B1801391 74C1802117 74C1802118 74D1800085 74D1801077 74E1800628 74E1800789 74E1802236 74F1800042 74E1803151 74F1801157 74G1800356 74H1800881 74H1802700 74K1800753 74L1802033 74M1800649 74A1900149 74A1901354 74A1901414 74B1900011 74B1900245 74B1902467 74D1901101 74D1903025 |
Recalling Firm/
Manufacturer |
TELEFLEX MEDICAL INC
3015 Carrington Mill Blvd
Morrisville NC 27560-5437
|
Manufacturer Reason
for Recall |
There is the potential for water to flood the column and enter the circuit under circumstances where an abnormal pressure differential is created between the water bottle and the column during high flow oxygen therapy.
|
FDA Determined
Cause 2 |
Device Design |
| Action |
The firm initiated the recall by letter on 12/13/2019. The firm is seeking the return of the product.
The firm requested the following actions be taken:
"1. If you have affected stock, immediately identify all patients that are currently exposed to use of this product, discontinue use and quarantine any products with the product codes and lot numbers listed above.
2. To acknowledge receipt of this Urgent Medical Device Recall Notice or to return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. This will allow us to document the amount of product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of products to Teleflex Medical.
3. If you have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. This will allow us to document your receipt of this letter.
If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-396-2111. |
| Quantity in Commerce |
127293 devices |
| Distribution |
nationwide |
| Total Product Life Cycle |
TPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
| 510(K) Database |
510(K)s with Product Code = BTT and Original Applicant = TELEFLEX, INC.
|
