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Terminated

ARROW EPIDURAL CATHETERIZATION KIT. Product No. MC-05001.

FDA Recall Z-1300-04 · Posted 2004-07-31

Recalling FirmArrow International Inc
Recall StatusTerminated
Product CodeCAZ
Date Initiated2004-06-07
Date Terminated2004-09-21
Product Quantity270 units

Reason for Recall

The recall is due to a confirmed packaging error of the wrong epidural needle (longer than stated).

Firm Action

The recalling firm sent a recall letter to its direct accounts to notify of the recall action and that the wrong epidural needle was packaged in the kits. The letter instructed the accounts to returned the kits to the recalling firm''s Asheboro, NC facility for rework and resterilization.

Root Cause

Other

Distribution Pattern

The recalled kits with the wrong epidural needle was distributed to the following direct accounts, to the following states in TN and TX

Official Source

View FDA Recall →

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

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