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Terminated

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

FDA Recall Z-0607-03 · Posted 2003-03-05

Recalling FirmNovartis Nutrition Corp
Recall StatusTerminated
Product CodeLZH
Date Initiated2003-01-27
Date Terminated2004-06-24
Product Quantity114 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.

K940556SANDOZ NUTRITION COMPAT(R) ENTERAL FEEDING PUMPSandoz Nutrition · 1994-11-07

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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