Recall Z-2281-2019

Canadian Hospital Specialties · initiated July 16, 2019

Class II Terminated

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

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

Codes / lots: 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

Reason for recall

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

FDA-determined cause: Under Investigation by firm

Action taken

The firm initiated the recall by email on 07/16/2019. The notice requested the consignee cease distribution/use of the product, complete and return the product recall response form to arrange for product return and replacement/credit.

Details

Recall number
Z-2281-2019
Initiated
July 16, 2019
Terminated
May 28, 2025
Product code
FPD – Tube, Feeding
Quantity
2870 units
Distribution
GA and TN
Recalling firm
Canadian Hospital Specialties, Oakville

Official FDA recall record