Z-1127-2022 Class II Ongoing
FDA device recall Z-1127-2022 was initiated by TELEFLEX MEDICAL INC on April 11, 2022 and is designated Class II. Reason for recall: Reports received of torn corrugated breathing tubes. The recall status is ongoing. Affected quantity: 290,809 eaches.
Recall Details
- Product Type
- Devices
- Report Date
- June 1, 2022
- Initiation Date
- April 11, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 290,809 eaches
Product Description
(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.
Reason for Recall
Reports received of torn corrugated breathing tubes.
Distribution Pattern
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.
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.