Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0607-03

Compat Enteral Delivery Pump Set with Piercing Spike, Item number 19930700

Novartis Nutrition Corp. / initiated 2003-01-27 / Terminated

Novartis Nutrition Corp began a recall of Compat Enteral Delivery Pump Set with Piercing Spike, Item number 19930700 on . The reason FDA records is "Some of the sets may leak or disconnect near the pump adapter during use. The patient could ingest air and vomit causing a safety concern". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0607-03
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Novartis Nutrition Corp.
Product
Compat Enteral Delivery Pump Set with Piercing Spike, Item number 19930700
Product code
LZH Pump, Infusion, Enteral
Reason for recall
Some of the sets may leak or disconnect near the pump adapter during use. The patient could ingest air and vomit causing a safety concern.
FDA root cause
Other
Action
The recall letter, dated January 31, 2003, requested that the consignees return the recalled products and notify 'end users' to stop using the products.
Quantity in commerce
114 cases (30 tube sets per case)
Distribution
Nationwide in the United States and to Canada
Product codes and lots
Item number 19930700, lot 3092D