Recalls / —

—#33792

Product

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

FDA product code

CAZ — Anesthesia Conduction Kit

Device class

Class 2

Medical specialty

Anesthesiology

Affected lot / code info

Lot No. RF4044686, expiration date 2006-09

Why it was recalled

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

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm

Arrow International Inc

Address

2400 Bernville Rd, Reading, Pennsylvania 19605-9607

Distribution

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

Timeline

Recall initiated

2004-06-07

Posted by FDA

2004-07-31

Terminated

2004-09-21

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #33792. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.