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Hudson RCI Sheridan EZ-ENDO recallZ-2313-2019 · Teleflex Medical · initiated Jul 30, 2019

Class I Terminated All recalls posted in September 2019

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Teleflex Medical or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube (ETT). Disconnection from the breathing circuit may result in insufficient oxygenation, requiring medical intervention.

FDA root cause category: Process control

What the company is doing

Teleflex sent an Urgent Medical Device Recall Notification letter dated July 30, 2019 to affected customers. The letter explains the problem and requests the consignee discontinue use and quarantine of any of the recalled products then to notify Teleflex. The firm is requesting the return of the affected products. For questions, contact your local sales representative or Customer Service at 1-866-396-2111.

Recall details

Recall number
Z-2313-2019
Recall class
Class I (most serious)
Status
Terminated
Initiated by the company
Jul 30, 2019
Posted by the FDA
Sep 9, 2019
Recalling firm
Teleflex Medical
Quantity
57181units
Product code
BTR
FDA submissions
K822082
Distribution
US Nationwide Distribution

Product description

Hudson RCI Sheridan EZ-ENDO: a) 5.0 mm, REF 5-22510 b) 5.5 mm, REF 5-22511 c) 7.0 mm, REF 5-22514 d) 7.5 mm, REF 5-22515 e) 8.0 mm, REF 5-22516 f) 8.5 mm, REF 5-22517 g) 9.0 mm, REF 5-22518 h) 6.0 mm, REF 5-22512 i) 6.5 mm, REF 5-22513 Product Usage: Tracheal tube/airway management

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

a) REF 5-22510 Batch numbers:  73B1700556 73D1700650 73H1700346 73H1800449  b) REF 5-22511 Batch numbers:  73C1700261 73K1700609 73C1800370  c) REF 5-22514 Batch numbers:  73A1700118 73C1700569 73E1700722 73F1700175 73F1700405 73G1700433 73H1700349 73H1700494 73H1700711 73J1700143 73K1700081 73K1700610 73L1700181 73M1700273 73D1800653 73F1800562 73F1800720 73H1800450 73J1800531 73K1800328 73K1800786  d) REF 5-22515 Batch numbers:  73B1700316 73C1700262 73C1700418 73E1700723 73E1700104 73F1700176 73F1700406 73G1700434 73H1700350 73J1700302 73J1700497 73K1700747 73M1700274 73A1800068 73A1800683 73B1800502 73C1800201 73D1800154 73E1800402 73F1800565 73G1800591 73H1800451 73H1800686 73J1800113 73K1800736  e) REF 5-22516 Batch numbers:  73K1600594 73A1700282 73B1700158 73B1700317 73C1700570 73F1700036 73F1700177 73F1700407 73G1700614 73H1700495 73J1700487 73K1700082 73A1800684 73B1800503 73C1800371 73E1800577 73G1800232 73J1800532 73K1800327  f) REF 5-22517 Batch numbers:  73J1600767 73C1800202  g) REF 5-22518 Batch numbers:  73K1600595 73E1800459 73M1800288  h) REF 5-22512 Batch numbers:  73K1600152 73M1600163 73A1700280 73C1700567 73E1700496 73F1700403 73H1700347 73M1700272 73E1800401 73E1800575 73F1800354  i) REF 5-22513 Batch numbers: 73J1600766 73B1700155 73C1700568 73F1700404 73G1700432 73H1700348 73E1800576 73F1800355

Other devices under the same FDA submission

60 devices cleared under K822082 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 83461).

Sources and updates

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