Medtronic Intersept 3608 Sterile tubing (8') 1/2 x 3/32 in. Quantity 10, Lot 7626621, Use by 2009-07-31. Manufacturer: M
FDA device recall Z-1227-2007 · posted 2007-09-25 · Terminated
Recall details
- Recalling firm
- Medtronic Perfusion Systems
- Reason for recall
- Medtronic Custom Tubing Packs might have open header bag seals.
- Action taken
- Certified letters dated 8/1/07 were sent to customers. The letter explains the situation and requests the impacted product to be returned to Medtronic for replacement or credit. The customers are being requested to complete a Recall Certificate acknowledging the receipt of the information.
- Root cause
- Other
- Status
- Terminated
- Product code
- DWE
- Quantity affected
- 853 packs
- Distribution
- Nationwide.
- Date initiated
- 2007-08-01
- Date posted
- 2007-09-25
- Date terminated
- 2008-10-10
- Location
- Brooklyn Park, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EXTRACORPOREAL CIRCUIT WITH BIO-ACTIVE SURFACE (K891687) | Medtronic Blood Systems, Inc. | 1989-05-31 |
| EXTRACORP.'S INTERSEPT CUS. TUBING PK. (K800178) | Extracorporeal Medical Specialities, Inc. | 1980-02-21 |