Wolf Medical Supply, Inc., WOLF-PAK REDI-FLO ELASTOMERIC INFUSION PUMP, FILL VOLUME 100 mL, FLOW RATE 2mL/Hr. Model # CT
FDA device recall Z-0268-2012 · posted 2011-11-23 · Terminated
Recall details
- Recalling firm
- Wolf Medical Supply Inc.
- Reason for recall
- Redi-Flo Elastomeric Infusion Pumps may have a higher flow rate than specified (more than +15%).
- Action taken
- On 10/20/2011 Wolf Medical Supply Inc., customers were notified by telephone and email. Product was distributed to end users.
- Root cause
- Process control
- Status
- Terminated
- Product code
- MEB
- Quantity affected
- 8 cases (192 units)
- Distribution
- Nationwide distribution, including Puerto Rico.
- Date initiated
- 2011-10-20
- Date posted
- 2011-11-23
- Date terminated
- 2012-04-25
- Location
- Fort Lauderdale, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMP (K081905) | Westmed, Inc. | 2008-07-15 |