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Recall Observatory FDA recall evidence

Device product

CE17TKFC EPIDURAL TRAY W/ 17GA TUOHY, Material Number 332079 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3333-2018

July 20, 2018

Class II

Product summary

Firm
B. Braun Medical, Inc.
Event
Event 80811
Status
Terminated
Classification
Class II
Quantity
69750
Official record key
device-enforcement:Z-3333-2018

Official wording

Reason: The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information: Batch: 61588411, 61589132, 61590240, 61591302, 61591816, 61592013, 61592513, 61594212, 61595169, 61595496, 61596322, 61596323, 61597455, 61597456, 61618678, 61614704, 61618680, 61618681, 61621829, 61621830, 61587111, 61587112

Distribution pattern: Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.