Mystic M-Style Mushroom Cup Mityvac Vacuum Assisted Delivery System Product No: 10047
FDA device recall Z-0005-05 · posted 2004-10-05 · Terminated
Recall details
- Recalling firm
- CooperSurgical, Inc.
- Reason for recall
- Product is mislabeled as a Mushroom Cap Vacuum but actually contains a Bell Style Assisted Delivery System
- Action taken
- CooperSurgical telephoned consignees on 8/18/04 and sales representatives to visit the account for removal of recalled product.
- Root cause
- Other
- Status
- Terminated
- Product code
- HDB
- Quantity affected
- 495 units
- Distribution
- FL, IA, KS, GA, MA, MN, MS, NE, NY, OH, OK, VA, ME, TX, VA Foreign: Italy
- Date initiated
- 2004-08-17
- Date posted
- 2004-10-05
- Date terminated
- 2012-05-10
- Location
- Trumbull, CT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MITYVAC (K011532) | Prism Enterprises, Inc. | 2001-07-30 |