Terumo Cardiovascular Procedure Kit Custom X-COATED HEART/LUNG FRAMEPACK P/N 71766PP
FDA device recall Z-2156-2010 · posted 2010-08-02 · Terminated
Recall details
- Recalling firm
- Terumo Cardiovascular Systems Corp
- Reason for recall
- Vent port may be occluded and prevent delivery of fluid
- Action taken
- Terumo, Ashland, MA notified consignees on 6/8/10, by phone, fax, email and mail to advise distributors and end-users of the required recall actions. Follow-up communication sent by priority overnight mail on 6/9/10, with proof of delivery, specifying the awareness to the issue and necessary correction activities should a unit be discovered. Phase 2 initiated on 7/1/10 to sale rep to remove recalled product and perform a product reconciliation to ensure that all affected product is identified, returned to Terumo CVS, and that replacement product is sent immediately.
- Root cause
- Equipment maintenance
- Status
- Terminated
- Product code
- DTR
- Quantity affected
- 32 packs
- Distribution
- Distribution USA and Canada
- Date initiated
- 2010-06-08
- Date posted
- 2010-08-02
- Date terminated
- 2012-05-07
- Location
- Ashland, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CLEAR CARDIOPLEJIA DELIVERY SYSTEM (K823451) | 3M Health Care, Sarns | 1983-01-14 |