Z-1357-2023 Class I Ongoing
FDA device recall Z-1357-2023 was initiated by Covidien on March 24, 2023 and is designated Class I. Reason for recall: A manufacturing error, resulted in a less than specified diameter of adult flexible tracheostomy tube connectors, which results in unsecure connections with 15mm caps and other 15mm circuit components… The recall status is ongoing. Affected quantity: 599,187.
Recall Details
- Product Type
- Devices
- Report Date
- April 26, 2023
- Initiation Date
- March 24, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 599,187
Product Description
Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, and Cuffless: Disposable Inner Cannula or Reusable Inner Cannula (REF, Product Description): 10CN10H, 10.0MM SHILEY CUFFED TRACH CAN; 10CN10R, 10.0MM ADT FLEX TRACH W TG CUFF; 10UN10A, 10.0MM UNCUFF TRACH TUBE X1; 10UN10H, 10.0MM SHILEY CUFFLESS TRACH C; 10UN10R, 10.0MM ADT FLEX TRACH CUFFLESS; 4CN65A, 6.5MM TRACH TUBE W TG CUFF X1; 4CN65H, 6.5MM SHILEY CUFFED TRACH CANN; 4CN65R, 6.5MM ADT FLEX TRACH W TG CUFF X1; 4UN65A, 6.5MM UNCUFF TRACH TUBE X1; 4UN65H, 6.5MM SHILEY CUFFLESS TRACH CA; 4UN65R, 6.5MM ADT FLEX TRACH CUFFLESSX1; 5CN70A, 7.0MM TRACH TUBE W TG CUFF X1; 5CN70H, 7.0MM SHILEY CUFFED TRACH CANN; 5CN70R, 7.0MM ADT FLEX TRACH W TG CUFF X1; 5UN70A, 7.0MM UNCUFF TRACH TUBE X1; 5UN70H, 7.0MM SHILEY CUFFLESS TRACH CA; 5UN70R, 7.0MM ADT FLEX TRACH CUFFLESSX1; 6CN75A, 7.5MM TRACH TUBE W TG CUFF X1; 6CN75H, 7.5MM SHILEY CUFFED TRACH CANN; 6CN75R, 7.5MM ADT FLEX TRACH W TG CUFF X1; 6UN75H, 7.5MM SHILEY CUFFLESS TRACH CA; 6UN75R, 7.5MM ADT FLEX TRACH CUFFLESSX1; 7CN80A, 8.0MM TRACH TUBE W TG CUFF X1; 7CN80H, 8.0MM SHILEY CUFFED TRACH CANN; 7CN80R, 8.0MM ADT FLEX TRACH W TG CUFF X1; 7UN80A, 8.0MM UNCUFF TRACH TUBE X1; 7UN80H, 8.0MM SHILEY CUFFLESS TRACH CA; 7UN80R, 8.0MM ADT FLEX TRACH CUFFLESSX1; 8CN85A, 8.5MM TRACH TUBE W TG CUFF X1; 8CN85H, 8.5MM SHILEY CUFFED TRACH CANN; 8CN85R, 8.5MM ADT FLEX TRACH W TG CUFF X1; 8UN85A, 8.5MM UNCUFF TRACH TUBE X1; 8UN85H, 8.5MM SHILEY CUFFLESS TRACH CA; 8UN85R, 8.5MM ADT FLEX TRACH CUFFLESSX1; 9CN90H, 9.0MM SHILEY CUFFED TRACH CANN; 9CN90R, 9.0MM ADT FLEX TRACH W TG CUFF X1; 9UN90H, 9.0MM SHILEY CUFFLESS TRACH CA; 9UN90R, 9.0MM ADT FLEX TRACH CUFFLESSX1
Reason for Recall
A manufacturing error, resulted in a less than specified diameter of adult flexible tracheostomy tube connectors, which results in unsecure connections with 15mm caps and other 15mm circuit components and accessories. An unsecure connection could lead to respiratory failure, dyspnea, treatment delay, tissue injury, or bleeding.
Distribution Pattern
Worldwide - US Nationwide distribution including in the states of PR, CA, FL, MN, PA, AZ, IL, TN, OH, MI, GA, KS, HI, MD, AK, NY, NE, IA, OK, VA, ND, MO, NC, SC, KY, OR, IN, WA, TX, WI, CT, MA, WV, CO, VT, NJ, SD, AR, AL, MS, LA, DE, MT, WY, DC, UT, NV, NH, RI, ID, NM, ME and the countries of Algeria, Andorra, Argentina, Australia, Austria, Bahamas, Bahrain, Belgium, Bolivia, Plurinational State Of Bosnia And Herzegovina, Brazil, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Cote D'Ivoire, Cyprus, Czech Republic, Denmark, El Salvador, Estonia, Finland, France, French Guiana, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, Indonesia, Ireland, Israel, Italy, Jordan, Kosovo, Kuwait, Lebanon, Lithuania, Luxembourg, Macao, Malaysia, Malta, Martinique, Mexico, Namibia, Netherlands, New Caledonia, New Zealand, North Macedonia, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, United Republic Of Tanzania, Thailand, Trinidad And Tobago, Turkey, United Arab Emirates, Viet Nam.
Code Information
REF/UDI-DI/Lot: 10CN10H/10884521172371/21C0402JZX, 21D0461JZX, 21G0457JZX, 21I0293JZX, 21I0294JZX, 21I0552JZX, 21J1435JZX, 21J1436JZX, 21K0275JZX, 21K0276JZX, 21K0277JZX, 21K0278JZX; 10CN10R/10884521205475/202107218X, 202107296X, 202108128X, 202108285X, 21H0792JZX, 21H0793JZX, 21H0794JZX, 22I0596JZX; 10UN10A/20884521175690/21D0463JZX; 10UN10H/20884521176291/21E0661JZX, 21G0473JZX; 10UN10R/10884521205543/202105307X, 202105308X, 202106148X, 202209335X; 4CN65A/10884521172456/21C0432JZX, 21I0369JZX; 4CN65H/20884521176307/21C0358JZX, 21C0359JZX, 21C0360JZX, 21C0361JZX, 21D0440JZX, 21D0441JZX, 21E0512JZX, 21E0513JZX, 21E0514JZX, 21E0515JZX, 21E0516JZX, 21E0517JZX, 21E0518JZX, 21E0519JZX, 21E0520JZX, 21E0521JZX, 21E0522JZX, 21E0523JZX, 21E0524JZX, 21E0525JZX, 21E0526JZX, 21E0527JZX, 21E1773JZX, 21E1774JZX, 21E1775JZX, 21E1776JZX, 21E1777JZX, 21E1778JZX, 21E1779JZX, 21E1780JZX, 21E1781JZX, 21E1782JZX, 21E1783JZX, 21H1324JZX, 21J0181JZX, 21J1094JZX, 21K0237JZX, 21K0239JZX, 21K0639JZX, 21K0643JZX, 21K0645JZX, 22C1465JZX, 22C1466JZX, 22C1467JZX, 22D0798JZX, 22D0799JZX, 22D0800JZX, 22D0801JZX, 22D0891JZX, 22D0892JZX, 22D0893JZX, 22D0897JZX, 22D0898JZX, 22D0899JZX, 22D0900JZX, 22D0901JZX, 22D0909JZX, 22F0918JZX, 22F0919JZX, 22F0920JZX, 22F0921JZX, 22F0922JZX, 22F0923JZX, 22F0924JZX, 22F0925JZX, 22F0926JZX, 22F0927JZX, 22F0928JZX, 22F0929JZX, 22J0073JZX, 22J0074JZX, 22J0075JZX, 22J0076JZX, 22J0077JZX, 22J0080JZX, 22J0081JZX, 22J0083JZX; 4CN65R/10884521205024/202105082X, 202105310X, 202106267X, 202106268X, 202107294X, 202107295X, 202111088X, 202111270X, 202111399X, 202112135X, 202201303X, 202202186X; 4UN65A/20884521175706/21D0466JZX, 21E0659JZX, 21E0660JZX; 4UN65H/20884521176239/21C0413JZX, 21C0414JZX, 21C0416JZX, 21C0417JZX, 21D0898JZX, 21D0899JZX, 21D0900JZX, 21D0901JZX, 21E1784JZX, 21E1785JZX, 22D0930JZX, 22D0931JZX, 22D0932JZX, 22D0933JZX, 22E0679JZX, 22E0680JZX; 4UN65R/10884521205482/202107297X, 202107298X, 202107299X, 202107300X, 202108122X, 202108123X, 202108124X, 202108125X, 202108139X, 202108140X, 202108228X, 202108229X, 21E1139JZX; 5CN70A/10884521172463/22D0927JZX, 22D0928JZX, 22D0929JZX, 22H0031JZX, 22H0032JZX, 22H0033JZX, 22H0860JZX, 22H0861JZX, 22H0863JZX, 22H0865JZX, 22J0071JZX, 22J0072JZX; 5CN70H/20884521176314/21C0404JZX, 21C0405JZX, 21C0406JZX, 21D0462JZX, 21G1130JZX, 21I0283JZX, 21I0284JZX, 21I0285JZX, 21I0286JZX, 21I0519JZX, 21I0520JZX, 21I0521JZX, 21I0522JZX, 21I0544JZX, 21I0545JZX, 21I0546JZX, 21I0630JZX, 21I0631JZX, 22D0924JZX, 22D0925JZX, 22D0926JZX, 22H0152JZX; 5CN70R/10884521205420/202111135X, 202208294X, 202208295X, 202210208X; 5UN70A/20884521175713/21B0062JZX, 21E0645JZX, 21E0646JZX, 21E0647JZX; 5UN70H/20884521176246/21E0655JZX, 21E0656JZX, 21G1008JZX, 21G1009JZX, 21H0735JZX; 5UN70R/10884521205499/202208296X; 6CN75A/10884521172470/22A0137JZX, 22H0868JZX; 6CN75H/20884521176321/21D0420JZX, 21D0421JZX, 21D0422JZX, 21D0423JZX, 21D0424JZX, 21D0425JZX, 21D0426JZX, 21D0427JZX, 21D0428JZX, 21D0429JZX, 21D0430JZX, 21D0431JZX, 21D0432JZX, 21D0433JZX, 21D0434JZX, 21D0435JZX, 21D0436JZX, 21D0437JZX, 21D0438JZX, 21D0439JZX, 21D0741JZX, 21D0742JZX, 21D0743JZX, 21D0744JZX, 21D0745JZX, 21D0746JZX, 21D0747JZX, 21D0748JZX, 21D0749JZX, 21E0632JZX, 21E0633JZX, 21E0634JZX, 21E0635JZX, 21E0636JZX, 21E0637JZX, 21E0638JZX, 21E0639JZX, 21E0640JZX, 21E0641JZX, 21E0642JZX, 21E0643JZX, 21E0644JZX, 21E1100JZX, 21E1101JZX, 21E1673JZX, 21E1674JZX, 21E1675JZX, 21E1676JZX, 21E1677JZX, 21E1678JZX, 21E1679JZX, 21E1680JZX, 21E1681JZX, 21E1682JZX, 21E1683JZX, 21E1684JZX, 21E1685JZX, 21E1686JZX, 21E1687JZX, 21E1688JZX, 21E1689JZX, 21E1690JZX, 21E1691JZX, 21E1694JZX, 21E1695JZX, 21E1696JZX, 21E1697JZX, 21E1769JZX, 21F0692JZX, 21F0693JZX, 21F0694JZX, 21G0296JZX, 21G0297JZX, 21G0298JZX, 21G0299JZX, 21G0426JZX, 21G0427JZX, 21G0428JZX, 21G0429JZX, 21G0430JZX, 21H0624JZX, 21I0260JZX, 21I0261JZX, 21I0262JZX, 21I0263JZX, 21I0264JZX, 21I0265JZX, 21I0266JZX, 21I0267JZX, 21I0268JZX, 21I0269JZX, 21I0270JZX, 21I0271JZX, 21I0491JZX, 21I0492JZX, 21I0680JZX, 21I0681JZX, 21I0682JZX, 21I0683JZX, 21J0090JZX, 21J0168JZX, 21J0169JZX, 21J0170JZX, 21J0171JZX, 21J0172JZX, 21J0176JZX, 21J0177JZX, 21J1088JZX, 21J1410JZX, 21J1411JZX, 21J1417JZX, 21J1418JZX, 21L0549JZX, 21L0550JZX, 21L0551JZX, 21L0552JZX, 21L0553JZX, 21L0756JZX, 21L0777JZX, 21L0778JZX, 21L0779JZX, 21L0796JZX, 21L0797JZX, 21L0801JZX, 21L0802JZX, 21L0803JZX, 21L0804JZX, 21L0805JZX, 21L0806JZX, 21L0807JZX, 21L0808JZX, 21L0809JZX, 21L0810JZX, 21L0811JZX, 21L0812JZX, 21L0813JZX, 21L0814JZX, 21L0815JZX, 21L0816JZX, 21L0817JZX, 21L0818JZX, 21L0819JZX 22A0665JZX, 22A0666JZX, 22A0670JZX, 22A0671JZX, 22A0672JZX, 22A0673JZX, 22A0674JZX, 22A0771JZX, 22A0772JZX, 22A0900JZX, 22A0901JZX, 22A0902JZX, 22A0903JZX, 22A0904JZX, 22A0905JZX, 22A0906JZX, 22A0907JZX, 22A0908JZX, 22A0909JZX, 22A0910JZX, 22A0911JZX, 22A0912JZX, 22A0913JZX, 22A0914JZX, 22A0915JZX, 22A0916JZX, 22B0277JZX, 22B0280JZX, 22B0288JZX, 22B0289JZX, 22B0290JZX, 22B0291JZX, 22B0334JZX, 22B0335JZX, 22B0336JZX, 22B0337JZX, 22C0758JZX, 22C0759JZX, 22D0936JZX, 22D0937JZX, 22D0938JZX, 22D0939JZX, 22D0940JZX, 22D0941JZX, 22D0942JZX, 22D0943JZX, 22D0944JZX, 22D0945JZX, 22D0946JZX, 22D0947JZX, 22D0948JZX, 22D0951JZX, 22D0952JZX, 22D0953JZX, 22D0954JZX, 22D0955JZX, 22D0956JZX, 22D0957JZX, 22D0958JZX, 22D0960JZX, 22D0961JZX, 22D0962JZX, 22D0963JZX, 22D0964JZX, 22D0965JZX, 22D0966JZX, 22D0967JZX, 22D0968JZX, 22D0969JZX, 22D0970JZX, 22D0971JZX, 22D0972JZX, 22G0403JZX, 22G0404JZX, 22G0405JZX, 22G0406JZX, 22G0407JZX, 22G0408JZX, 22G0414JZX, 22G0420JZX, 22H0872JZX, 22H0873JZX, 22H0874JZX, 22H0875JZX, 22H0877JZX, 22H0881JZX, 22H0886JZX, 22H0887JZX, 22J0084JZX, 22J0085JZX, 22J0086JZX, 22J0093JZX, 22J0094JZX, 22J0095JZX, 22J0096JZX, 22J0097JZX, 22J0098JZX, 22J0099JZX, 22J0100JZX, 22J0101JZX, 22J0102JZX, 22J0103JZX, 22J0104JZX, 22J0187JZX, 22J0189JZX, 22J0190JZX, 22J0191JZX, 22J0192JZX, 22J0193JZX, 22J0194JZX, 22J0196JZX, 22J0197JZX, 22J0198JZX, 22J0206JZX, 22K0244JZX, 22K1921JZX, 22K1922JZX, 22K1983JZX; 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