Z-0595-2016 Class II Terminated
FDA device recall Z-0595-2016 was initiated by Benlan, Inc. on December 11, 2015 and is designated Class II. Reason for recall: The product may be packaged with a 5 or 6.5FR tube instead of an 8FR size. The recall status is terminated (terminated October 31, 2016). Affected quantity: 120 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 13, 2016
- Initiation Date
- December 11, 2015
- Termination Date
- October 31, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 120 units
Product Description
MED-RX Single Use REF 54-3680R, 8 FR. x 36" (91CM) Polyurethane Feeding Tube For Pediatric Use with Orange Radiopaque Stripe and Enteral Connector, Made in Canada, Benton, Oakville, Ontario, Canada
Reason for Recall
The product may be packaged with a 5 or 6.5FR tube instead of an 8FR size.
Distribution Pattern
Worldwide Distribution - US including GA & Internationally to Canada.
Code Information
Lots 114842, 116433 & 118251