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