Shelhigh No-React Pulmonic Valve Conduit. **'Shelhigh No-React, Pulmonic Valve Conduit, NR4000-PA-C'** **'Shelhigh, Inc.
FDA device recall Z-0678-06 · posted 2006-03-25 · Terminated
Recall details
- Recalling firm
- Shelhigh, Inc.
- Reason for recall
- Unapproved Device-Distribution of an unapproved device into interstate commerce.
- Action taken
- The firm retrieved the 6 devices from the consignees identified, following a telephone request on 1/18/2006. The firm does not consider this a recall.
- Root cause
- Other
- Status
- Terminated
- Product code
- MWH
- Quantity affected
- 25 units
- Distribution
- The devices were supplied directly to hospital and Shelhigh sales reps. There are two main accounts: Children's Hopsital of Boston, MA and Products for Surgery, Scottsdale, AZ (Shelhigh authorized sal
- Date initiated
- 2006-01-18
- Date posted
- 2006-03-25
- Date terminated
- 2007-05-23
- Location
- Union, NJ
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