Z-1763-2019Class I

Hudson RCI Sheridan: 1) Uncuffed 6.0 mm, Product Code 5-10412 2) Uncuffed 6.5 mm, Product Code 5-10413 3)...

Name: Z-1763-2019 Hudson RCI Sheridan: 1) Uncuffed 6.0 mm, Product Code 5-10412 2) Uncuffed 6.5 mm, Product Code 5-10413 3)...
Creator: Teleflex Medical
Published: 2019-05-24
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2019-05-24 / Terminated / root cause: manufacturing process

FDA source

Teleflex Medical began a recall of Hudson RCI Sheridan: 1) Uncuffed 6.0 mm, Product Code 5-10412 2) Uncuffed 6.5 mm, Product Code 5-10413 3) Uncuffed 7.0 mm, Product Code 5-10414 Product Usage... on 2019-05-24. FDA classified it as Class I and gives the reason as "This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product) indicating that there is an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1763-2019
Classification: Class I
Status: Terminated
Initiated: 2019-05-24
Posted: 2019-06-19
Terminated: 2022-02-15
Recalling firm: Teleflex Medical
Product: Hudson RCI Sheridan: 1) Uncuffed 6.0 mm, Product Code 5-10412 2) Uncuffed 6.5 mm, Product Code 5-10413 3) Uncuffed 7.0 mm, Product Code 5-10414 Product Usage: Tracheal tube/airway management
Product code: BTR Tube, Tracheal (W/Wo Connector)
Reason for recall: This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product) indicating that there is an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the Endotracheal tube.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Teleflex sent an Urgent Medical Device Recall letter dated May 24, 2019 to customers. The letter identified the affected product, problem and actions to be taken. The letter directed customers to discontinue use, quarantine the product, and contact Teleflex for return of the product. Distributors were directed to notify their customers and request the customer return the recalled products to them for consolidation and subsequent return to Teleflex.. For questions contact your local sales representative or Customer Service at 1-866-396-2111
Quantity in commerce: 14357
Distribution: Worldwide - US Nationwide Distribution
Product codes and lots: 1) Uncuffed 6.0 mm, Product Code 5-10412 Lot Numbers: 73J1600363 73K1600581 73L1600347 73L1600552 73L1600850 73M1600138 73A1700264 73B1700300 73C1700688 73E1700098 73E1700712 73G1700132 73H1700327 73J1700290 73K1700065 73K1700415 73L1700169 73L1700320 73M1700250 73A1800060 73B1800348 73B1800487 73C1800349 73C1800482 73D1800464 73E1800389 73F1800171 73G1800923 2) Uncuffed 6.5 mm, Product Code 5-10413 Lot Numbers: 73M1600139 73B1700301 73E1700472 73G1700127 73K1700416 73A1800061 73B1800349 73B1800488 73D1800634 73F1800544 73G1800924 3) Uncuffed 7.0 mm, Product Code 5-10414 Lot Numbers: 73A1700100 73F1700064 73L1800406

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1763-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1759-2019	Class I	Terminated	Voluntary: Firm initiated	2019-06-26	2019-06-19
Z-1760-2019	Class I	Terminated	Voluntary: Firm initiated	2019-06-26	2019-06-19
Z-1761-2019	Class I	Terminated	Voluntary: Firm initiated	2019-06-26	2019-06-19
Z-1762-2019	Class I	Terminated	Voluntary: Firm initiated	2019-06-26	2019-06-19
Z-1763-2019	Class I	Terminated	Voluntary: Firm initiated	2019-06-26	2019-06-19
Z-1764-2019	Class I	Terminated	Voluntary: Firm initiated	2019-06-26	2019-06-19
Z-1765-2019	Class I	Terminated	Voluntary: Firm initiated	2019-06-26	2019-06-19
Z-1766-2019	Class I	Terminated	Voluntary: Firm initiated	2019-06-26	2019-06-19

Product code BTR

K822082Class IISheridan/hvt,cf, UncuffedSheridan Catheter Corp. / cleared 1982-08-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)