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Terminated

Auto Suture IRRIVAC MAX Suction irrigation sytem with 5 mm, 33 cm probe with double spike tubing. Sterile, single use. Catalog # 200-20. Tyco/Healthcare/United States Surgical brand

FDA Recall Z-0261-04 · Posted 2004-07-20

Recalling FirmVital Concepts, Inc.
Recall StatusTerminated
Product CodeBYY
Date Initiated2003-11-07
Date Terminated2004-09-13
Product Quantity3045

Reason for Recall

The probe may separate from the cannula.

Firm Action

Recall letters dated November 7, 2003 were sent to each consignee asking them to return any remaining products in inventory or in the field.

Root Cause

Other

Distribution Pattern

Arizona, Illinois, Indiana, Michigan and Pennsylvania.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K934382VCI SUCTION/IRRIGATION TUBING SETVital Concepts, Inc. · 1994-02-01

Official Source

View FDA Recall →

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

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