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U.S. Department of Health and Human Services

Class 1 Device Recall Portex Endotracheal Tube Holders

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  Class 1 Device Recall Portex Endotracheal Tube Holders see related information
Date Initiated by Firm July 07, 2014
Date Posted August 28, 2014
Recall Status1 Terminated 3 on May 26, 2021
Recall Number Z-2537-2014
Recall Event ID 68739
510(K)Number K790312  
Product Classification Tube, tracheal (w/wo connector) - Product Code BTR
Product H4001S Neonatal/Paed.Intubation Kit 2.5mm Murphy,15mm Conn, Holder

Pediatric Endotracheal Intubation Kit
Code Information Lot Numbers: 2470637, 2470636, 2457747, 2448649, 2443371, 2438610, 2438609, 2428204, 2428203, 2423483, 2412132, 2405733, 2405732, 2394049, 2394048, 2394047, 2389237, 2389236, 2385647, 2380340, 2376638, 2376473, 2371941, 2365534, 2361589, 2357817, 2357816, 2353342, 2347040, 2343290, 2339700, 2335460, 2326892, 2322812, 2309462, 2298736, 2298735, 2286584, 2278061, 2263550, 2260549, 2250041, 2233738, 2228354, 2219206, 2211922, 2208179,  2191911, 2188447, 2179221, 2175047, 2154527, 2152029, 2142174, 2128628, 2119944, 2109010, 2099495, 2090213, 2068117, 2063968, 2063967, 2042403, 12049, 12047, 12044, 11669, 11403
Recalling Firm/
Manufacturer		 Smiths Medical ASD, Inc.
10 Bowman Dr
Keene NH 03431-5043
For Additional Information Contact
866-216-8806
Manufacturer Reason
for Recall		 The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause difficulty when locking the ET Tube Holder in place or difficulty when passing a suction catheter.
FDA Determined
Cause 2		 Process change control
Action Smiths Medical sent an Urgent Medical Device Recall Notice dated July 11, 2014, to all affected customers. The letter informed customers of the recall and instructed them to inspect their inventory and segregate any unused affected products and to complete and return the Recall Confirmation Form, by Fax 1-800-621-2590 or email to endotrachealtubeholders@smiths-medical.com. Customers with questions were instructed to call Smiths Medical's Customer Service Department at 1-800-258-5361. For questions regarading this recall call 866-216-8806.
Quantity in Commerce 135,518 (110,246 nationwide)
Distribution Worldwide Distribution - USA including AK, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV and Internationally to CA, CY, GB, IE, IT, JE, KW, MT, PL, RU, SA, ZA.
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 = BTR and Original Applicant = RESPIRATORY SUPPORT PRODUCTS, INC.
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