Compat 500 mL Baggle Top Fill Enteral Feeding Container with Preattached Enteral Delivery Pump Set, Item number 19931200
FDA Recall Z-0608-03 · Posted 2003-03-05
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Recalling FirmNovartis Nutrition Corp
Recall StatusTerminated
Product CodeLZH
Date Initiated2003-01-27
Date Terminated2004-06-24
Product Quantity803 cases (30 tube sets per case)
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.
Firm 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.
Root Cause
Other
Distribution Pattern
Nationwide in the United States and to Canada
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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