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Class 2 Device Recall Teleflex Flex Tube and SmoothFlo |
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| Date Initiated by Firm |
April 11, 2022 |
| Create Date |
May 24, 2022 |
| Recall Status1 |
Open3, Classified |
| Recall Number |
Z-1127-2022 |
| Recall Event ID |
90014 |
| Product Classification |
Set, tubing and support, ventilator (w harness) - Product Code BZO
|
| Product |
(1) Teleflex Flex tube, Product #20011, sterile;
(2) Teleflex Smooth-Flo Flex with Double Swivel, Product #22511, sterile;
(3) Teleflex Smooth-Flo Flex with Double Swivel, Product #22512, non-sterile;
(4) Teleflex Smooth-Flo Flex, Product #22552, non-sterile. |
| Code Information |
Batch and UDI numbers:
(1) Product 20011:
KMH21F0393 (01)04026704388769(17)260528(10)KMH21F0393;
KMH21F0394 (01)04026704388769(17)260528(10)KMH21F0394;
KMH21F0395 (01)04026704388769(17)260528(10)KMH21F0395;
KMH21F0412 (01)04026704388769(17)260528(10)KMH21F0412;
KMH21H0094 (01)04026704388769(17)260728(10)KMH21H0094;
KMH21H0095 (01)04026704388769(17)260728(10)KMH21H0095;
KMH21H0096 (01)04026704388769(17)260728(10)KMH21H0096;
KMH21H0110 (01)04026704388769(17)260728(10)KMH21H0110;
KMH21H0112 (01)04026704388769(17)260728(10)KMH21H0112;
KMH21J0109 (01)04026704388769(17)260828(10)KMH21J0109;
KMH21J0110 (01)04026704388769(17)260828(10)KMH21J0110;
KMH21J0118 (01)04026704388769(17)260828(10)KMH21J0118;
KMH21J0121 (01)04026704388769(17)260828(10)KMH21J0121;
KMH21J0124 (01)04026704388769(17)260828(10)KMH21J0124;
KMH21K0302 (01)04026704388769(17)260928(10)KMH21K0302;
KMH21K0303 (01)04026704388769(17)260928(10)KMH21K0303;
KMH21K0306 (01)04026704388769(17)260928(10)KMH21K0306;
KMH21K0307 (01)04026704388769(17)260928(10)KMH21K0307;
KMH21K0308 (01)04026704388769(17)260928(10)KMH21K0308;
KMH21K0320 (01)04026704388769(17)260928(10)KMH21K0320;
KMH21K0341 (01)04026704388769(17)260928(10)KMH21K0341;
KMH21K0345 (01)04026704388769(17)260928(10)KMH21K0345;
KMH21L0156 (01)04026704388769(17)261028(10)KMH21L0156;
KMH21B0479 (01)04026704388769(17)260128(10)KMH21B0479;
KMH21B0480 (01)04026704388769(17)260128(10)KMH21B0480;
KMH21B0482 (01)04026704388769(17)260128(10)KMH21B0482;
KMH21B0483 (01)04026704388769(17)260128(10)KMH21B0483;
KMH21C0229 (01)04026704388769(17)260228(10)KMH21C0229;
KMH21C0230 (01)04026704388769(17)260228(10)KMH21C0230;
KMH21C0231 (01)04026704388769(17)260228(10)KMH21C0231;
KMH21C0232 (01)04026704388769(17)260228(10)KMH21C0232;
KMH21C0241 (01)04026704388769(17)260228(10)KMH21C0241;
KMH21C0242 (01)04026704388769(17)260228(10)KMH21C0242;
KMH21C0245 (01)04026704388769(17)260228(10)KMH21C0245;
KMH21C0246 (01)04026704388769(17)260228(10)KMH21C0246;
KMH21C0252 (01)04026704388769(17)260228(10)KMH21C0252;
KMH21C0366 (01)04026704388769(17)260228(10)KMH21C0366;
KMH21C0367 (01)04026704388769(17)260228(10)KMH21C0367;
KMH21C0368 (01)04026704388769(17)260228(10)KMH21C0368;
KMH21C0377 (01)04026704388769(17)260228(10)KMH21C0377;
KMH21C0378 (01)04026704388769(17)260228(10)KMH21C0378;
KMH21D0204 (01)04026704388769(17)260328(10)KMH21D0204;
KMH21D0205 (01)04026704388769(17)260328(10)KMH21D0205;
KMH21D0206 (01)04026704388769(17)260328(10)KMH21D0206;
KMH21E0002 (01)04026704388769(17)260428(10)KMH21E0002;
KMH21E0003 (01)04026704388769(17)260428(10)KMH21E0003;
KMH21E0004 (01)04026704388769(17)260428(10)KMH21E0004;
KMH21F0196 (01)04026704388769(17)260528(10)KMH21F0196;
KMH21F0197 (01)04026704388769(17)260528(10)KMH21F0197;
KMH21F0198 (01)04026704388769(17)260528(10)KMH21F0198;
KMH21F0199 (01)04026704388769(17)260528(10)KMH21F0199; and
KMH21F0210 (01)04026704388769(17)260528(10)KMH21F0210.
(2) Product 22511
KMH21F0419 (01)04026704388783(17)260528(10)KMH21F0419;
KMH21F0433 (01)04026704388783(17)260528(10)KMH21F0433;
KMH21G0362 (01)04026704388783(17)260628(10)KMH21G0362;
KMH21G0363 (01)04026704388783(17)260628(10)KMH21G0363;
KMH21G0439 (01)04026704388783(17)260628(10)KMH21G0439;
KMH21H0061 (01)04026704388783(17)260728(10)KMH21H0061;
KMH21H0171 (01)04026704388783(17)260728(10)KMH21H0171;
KMH21H0199 (01)04026704388783(17)260728(10)KMH21H0199;
KMH21H0222 (01)04026704388783(17)260728(10)KMH21H0222;
KMH21H0248 (01)04026704388783(17)260728(10)KMH21H0248;
KMH21J0209 (01)04026704388783(17)260828(10)KMH21J0209;
KMH21J0220 (01)04026704388783(17)260828(10)KMH21J0220;
KMH21K0168 (01)04026704388783(17)260928(10)KMH21K0168;
KMH21K0376 (01)04026704388783(17)260928(10)KMH21K0376;
KMH21K0385 (01)04026704388783(17)260928(10)KMH21K0385;
KMH21B0490 (01)04026704388783(17)260128(10)KMH21B0490;
KMH21C0159 (01)04026704388783(17)260228(10)KMH21C0159;
KMH21C0160 (01)04026704388783(17)260228(10)KMH21C0160;
KMH21D0172 (01)04026704388783(17)260328(10)KMH21D0172;
KMH21D0316 (01)04026704388783(17)260328(10)KMH21D0316;
KMH21D0360 (01)04026704388783(17)260328(10)KMH21D0360;
KMH21E0024 (01)04026704388783(17)260428(10)KMH21E0024;
KMH21E0223 (01)04026704388783(17)260428(10)KMH21E0223;
KMH21F0148 (01)04026704388783(17)260528(10)KMH21F0148;
KMH21F0232 (01)04026704388783(17)260528(10)KMH21F0232; and
KMH21F0272 (01)04026704388783(17)260528(10)KMH21F0272.
(3) Product 22512:
KMZ21F0898 (01)04026704388790(17)260528(10)KMZ21F0898;
KMZ21G0757 (01)04026704388790(17)260628(10)KMZ21G0757;
KMZ21G0865 (01)04026704388790(17)260628(10)KMZ21G0865;
KMZ21H0006 (01)04026704388790(17)260728(10)KMZ21H0006;
KMZ21H0106 (01)04026704388790(17)260728(10)KMZ21H0106;
KMZ21J0245 (01)04026704388790(17)260828(10)KMZ21J0245;
KMZ21J0302 (01)04026704388790(17)260828(10)KMZ21J0302;
KMZ21J0504 (01)04026704388790(17)260828(10)KMZ21J0504;
KMZ21J0505 (01)04026704388790(17)260828(10)KMZ21J0505;
KMZ21J0538 (01)04026704388790(17)260828(10)KMZ21J0538;
KMZ21L0084 (01)04026704388790(17)261028(10)KMZ21L0084;
KMZ21L0407 (01)04026704388790(17)261028(10)KMZ21L0407;
KMZ21L0660 (01)04026704388790(17)261028(10)KMZ21L0660;
KMZ21C0007 (01)04026704388790(17)260228(10)KMZ21C0007;
KMZ21C0166 (01)04026704388790(17)260228(10)KMZ21C0166;
KMZ21C0372 (01)04026704388790(17)260228(10)KMZ21C0372;
KMZ21C0422 (01)04026704388790(17)260228(10)KMZ21C0422;
KMZ21C0722 (01)04026704388790(17)260228(10)KMZ21C0722;
KMZ21C0744 (01)04026704388790(17)260228(10)KMZ21C0744;
KMZ21C0924 (01)04026704388790(17)260228(10)KMZ21C0924;
KMZ21C1306 (01)04026704388790(17)260228(10)KMZ21C1306;
KMZ21D0858 (01)04026704388790(17)260328(10)KMZ21D0858;
KMZ21D0926 (01)04026704388790(17)260328(10)KMZ21D0926;
KMZ21D1057 (01)04026704388790(17)260328(10)KMZ21D1057;
KMZ21D1116 (01)04026704388790(17)260328(10)KMZ21D1116;
KMZ21E0135 (01)04026704388790(17)260428(10)KMZ21E0135;
KMZ21E0203 (01)04026704388790(17)260428(10)KMZ21E0203;
KMZ21E0360 (01)04026704388790(17)260428(10)KMZ21E0360;
KMZ21F0387 (01)04026704388790(17)260528(10)KMZ21F0387;
KMZ21F0554 (01)04026704388790(17)260528(10)KMZ21F0554;
KMZ21F0595 (01)04026704388790(17)260528(10)KMZ21F0595; and
KMZ21F0702 (01)04026704388790(17)260528(10)KMZ21F0702.
(4) Product 22552
KMZ21G0680 (01)04026704388851(17)260628(10)KMZ21G0680;
KMZ21G0689 (01)04026704388851(17)260628(10)KMZ21G0689;
KMZ21G0711 (01)04026704388851(17)260628(10)KMZ21G0711;
KMZ21G0801 (01)04026704388851(17)260628(10)KMZ21G0801;
KMZ21H0181 (01)04026704388851(17)260728(10)KMZ21H0181;
KMZ21H0182 (01)04026704388851(17)260728(10)KMZ21H0182;
KMZ21J0246 (01)04026704388851(17)260828(10)KMZ21J0246;
KMZ21J0401 (01)04026704388851(17)260828(10)KMZ21J0401;
KMZ21J0584 (01)04026704388851(17)260828(10)KMZ21J0584;
KMZ21K0364 (01)04026704388851(17)260928(10)KMZ21K0364;
KMZ21K0365 (01)04026704388851(17)260928(10)KMZ21K0365;
KMZ21K0608 (01)04026704388851(17)260928(10)KMZ21K0608;
KMZ21B1212 (01)04026704388851(17)260128(10)KMZ21B1212;
KMZ21B1213 (01)04026704388851(17)260128(10)KMZ21B1213;
KMZ21B1241 (01)04026704388851(17)260128(10)KMZ21B1241;
KMZ21C0130 (01)04026704388851(17)260228(10)KMZ21C0130;
KMZ21C1266 (01)04026704388851(17)260228(10)KMZ21C1266;
KMZ21D0957 (01)04026704388851(17)260328(10)KMZ21D0957;
KMZ21F0181 (01)04026704388851(17)260528(10)KMZ21F0181;
KMZ21F0182 (01)04026704388851(17)260528(10)KMZ21F0182; and
KMZ21F0518 (01)04026704388851(17)260528(10)KMZ21F0518. |
Recalling Firm/
Manufacturer |
TELEFLEX MEDICAL INC
3015 Carrington Mill Blvd
Morrisville NC 27560-5437
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Manufacturer Reason
for Recall |
Reports received of torn corrugated breathing tubes.
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FDA Determined
Cause 2 |
Device Design |
| Action |
The recalling firm issued letters dated April 2022 on 4/11/2022 via FedEx 2-day mail. The letter described the issue, the immediate actions required including the hazards involved, and provided specific actions to be taken and instructions to be followed by the medical facilities or the distributors.
For the medical facilities, they are to cease use and distribution of the impacted product and immediately quarantine it. If the product is in inventory, indicate the information on the Acknowledgment Form and FAX it to Customer Service or email it to the firm. A customer service representative will contact the medical facility with a Return Goods Authorization number and provide instructions for return of the product to Teleflex. The Acknowledgment Form should also be returned if no product is in inventory.
For distributors, they are to provide the recall letter to all customers who have received the product. Each customer is required to complete and return the Acknowledgement Form. The distributor is also supposed to check their inventory, cease distribution and quarantine the affected product. The Acknowledgment Form is to be completed and returned for product in their inventory as well as if they have no inventory. If the distributor has distributed product outside of the country, they are to notify Teleflex Customer Service.
Additionally, the recall letter says that this notice should be passed onto all persons who need to be aware within their organization or to any organizations where the potentially affected devices have been transferred. This would include users, clinicians, risk managers, supply chain/distribution centers, etc. in the circulation of the notice. |
| Quantity in Commerce |
290,809 eaches |
| Distribution |
Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NV, NY, OH, PA, SC, TN, TX, UT, VA, WA, WI, and WV. The countries of Austria, Australia, Belgium, Canada, Chile, Czech Republic, Finland, France, Germany, Greece, Hong Kong, Hungary, Korea, Malaysia, Netherlands, Panama, Poland, Slovakia, Spain, and Switzerland. |
| Total Product Life Cycle |
TPLC Device Report
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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.
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