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Terminated

20 French Ross Inverta-PEG Over-the-Guidewire Basic Gastrostomy KIt with Roll-Tip Bumper (list # 51490).

FDA Recall Z-0336-05 · Posted 2004-12-21

Recalling FirmAbbott Laboratories
Recall StatusTerminated
Product CodeLNO
Date Initiated2004-11-12
Date Terminated2007-02-21
Product Quantity3653 gastrostomy kits.

Reason for Recall

Gastrostomy and Jejunostomy primary placement kits which may contain components that may not have been adequately sterilized, were distributed.

Firm Action

The recalling firm notified customers by letter, dated 11/12/04.

Root Cause

Other

Distribution Pattern

The product was distributed throughout the United States and to foreign consignees located in Australia, Korea, Thailand, Venezuela, and Puerto Rico.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K932861FLEXIFLO GASTROSTOMY KITAbbott Laboratories · 1994-06-09

Official Source

View FDA Recall →

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

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