Recall Z-0269-2012 ยท MEB Pump, Infusion, Elastomeric
Wolf Medical Supply Inc.
Wolf Medical Supply Inc., WOLF-PAK REDI-FLO ELASTOMERIC INFUSION PUMP, FILL VOLUME 270 mL, FLOW RATE 2mL/Hr. Model # CT-0020-270 Item # RFC270020. Manufactured by Medpro International (Thailand) Ltd.
| Date | Nov 23, 2011 (initiated Oct 20, 2011) |
| Status | Terminated |
| Reason | Redi-Flo Elastomeric Infusion Pumps may have a higher flow rate than specified (more than +15%). |
| Root cause | Process control |
| Action | On 10/20/2011 Wolf Medical Supply Inc., customers were notified by telephone and email. Product was distributed to end users. |
| Quantity | 24 cases (576 units) |
| Distribution | Nationwide distribution, including Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081905 | ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMP Westmed, Inc., Jul 15, 2008 |