Z-2281-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 21, 2019
- Initiation Date
- July 16, 2019
- Termination Date
- May 28, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2870 units
Product Description
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
Reason for Recall
The firm received a complaint that the connector detached from the feeding tube.
Distribution Pattern
GA and TN
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