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Terminated

CIVCO Latex-Free Needle Guide, Sterile transrectal needle guide for use with Shimadzu UB1OR-065U transducer, Part #677-057, packaged 1 needle guide per tyvek pouch, 20 pouches per box. The label shows the product is Mfg by CIVCO, Kalona, IA.

FDA Recall Z-1054-2008 · Posted 2008-03-19

Recalling FirmCivco Medical Instruments Inc
Recall StatusTerminated
Product CodeITX
Date Initiated2008-01-16
Date Terminated2008-04-03
Product QuantityLot M102250 - 5 boxes; Lot M105440 - 2 boxes

Reason for Recall

Incorrect Needle Guide- The individual pouches contained V53W Endocavity Needle guide(p/n/034-054) instead of the Shimadzu T/R Needle guide (p/n134-054).

Firm Action

On 1/16/08, the recalling firm contacted their customers and notified them of the problem. Pictures of the problems were provided for identification. The firm requested that all products be returned.

Root Cause

Packaging

Distribution Pattern

Nationwide Distribution- including states of TX and GA

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K970514DISPOSABLE TRANSRECTAL/TRANSVAGINAL/ENDOCAVITY ULTRASOUND NEEDLE INSTRUMENT GUIDECIVCO Medical Instruments Co., Inc. · 1997-06-20

Official Source

View FDA Recall →

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

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