ARROW EPIDURAL CATHETERIZATION KIT. Product No. MC-05001.
FDA device recall Z-1300-04 · posted 2004-07-31 · Terminated
Recall details
- Recalling firm
- Arrow International Inc
- Reason for recall
- The recall is due to a confirmed packaging error of the wrong epidural needle (longer than stated).
- Action taken
- 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
- Status
- Terminated
- Product code
- CAZ
- Quantity affected
- 270 units
- Distribution
- The recalled kits with the wrong epidural needle was distributed to the following direct accounts, to the following states in TN and TX
- Date initiated
- 2004-06-07
- Date posted
- 2004-07-31
- Date terminated
- 2004-09-21
- Location
- Reading, PA
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