Tubing Set for TEM-Combined System; the tube set consists of a rectal pressure measuring tube, an insufflation tube, an
FDA device recall Z-1430-06 · posted 2006-08-24 · Terminated
Recall details
- Recalling firm
- Richard Wolf Medical Instruments Corp.
- Reason for recall
- The irrigation tubing in the tube set was assembled incorrectly with the connectors reversed.
- Action taken
- Richard Wolf field sales representatives telephoned the end users on 7/7/06, informing them that the blue connectors on the irrigation tube may be reversed in the tube set bundle for lot 060232 only. The end users were requested to return the affected lot of tubes for replacement at no charge, contacting Ms. Ellen Huffman at 800-323-9653, ext. 280 to make arrangements for the exchange of product. Any questions concerning the recall were directed to Ms. Huffman or Robert Casarsa at the same number.
- Root cause
- Other
- Status
- Terminated
- Product code
- HIF
- Quantity affected
- 100 sets
- Distribution
- Nationwide distribution --- including the states of Alabama, Florida, District of Columbia, Michigan, Minnesota, Nebraska, New York, Ohio, Oregon, Pennsylvania, Utah, Vermont and Wisconsin.
- Date initiated
- 2006-07-07
- Date posted
- 2006-08-24
- Date terminated
- 2007-06-15
- Location
- Vernon Hills, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TRANSANAL ENDOSCOPIC MICROSURGERY (TEM) COMBINATION SYSTEM AND INSTRUMENT SET, INSTRUMENT SET FOR THE TRANSANAL ENDOSCOP (K000180) | Richard Wolf Medical Instruments Corp. | 2001-03-02 |