Skip to content
Recall Observatory FDA recall evidence

Device product

MED-RX POLYURETHANE FEEDING TUBES: a) 5Fr X 16" (40cm), REF 54-1650R b) 6.5Fr X16" (40cm), REF 54-1665R c) 5Fr X 24" (60cm), REF 54-2450R d) 6.5Fr X 24" (60cm), REF 54-2465R e) 8Fr X 24: (60cm), REF 54-2480R f) 8Fr X 36" (91cm), REF 54-3680R

Z-2281-2019

July 16, 2019

Class II

Product summary

Firm
Canadian Hospital Specialties
Event
Event 83374
Status
Terminated
Classification
Class II
Quantity
2870 units
Official record key
device-enforcement:Z-2281-2019

Official wording

Reason: The firm received a complaint that the connector detached from the feeding tube.

Code information: a) 5Fr X 16" (40cm), REF 54-1650R, Lot Number 141487 b) 6.5Fr X16" (40cm), REF 54-1665R, Lot Number 141863 c) 5Fr X 24" (60cm), REF 54-2450R, Lot Numbers: 142844, 143130 d) 6.5Fr X 24" (60cm), REF 54-2465R, Lot Number 142843 e) 8Fr X 24: (60cm), REF 54-2480R, Lot Number 142870 f) 8Fr X 36" (91cm), REF 54-3680R, Lot Number 142842

Distribution pattern: GA and TN

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The firm received a complaint that the connector detached from the feeding tube.