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Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff
and CufflessDisposable Inner Cannula or Reusable Inner Cannula (REF
Product Description)
76 of 76 codes
- 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

Lot codes and dates: 38 of 38 products · 1,025 lot codes
Recalled lot codes, grouped by product number
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
Page 1 of 4
Amount recalled: 599,187

Where it was sold

Why it was recalled

Stop using this product now

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.

Using this product could cause serious injury, illness or death — stop using it now.

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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where it was distributed

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Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, and Cuffless: Disposable Inner Cannula or Reusable Inner…

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Where it was sold

Why it was recalled

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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`

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