Medrad(R) Continuum MR Infusion System Secondary VSA Set Peristaltic Pump System designed for patients who require medic
FDA device recall Z-0604-2013 · posted 2012-12-20 · Terminated
Recall details
- Recalling firm
- Medrad Inc
- Reason for recall
- Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and microbore), catalog numbers MIK200A, MIL 200B, 3015153, 3015155, 3015156, 3015157, 3015158, 3015159, and 3015161. The firm is initiating this recall because this tubing exhibits a variation that, when used in conjunction with any Continuum pump, may result in flow rate accuracy performance issues.
- Action taken
- The firm, Bayer HealthCare, sent an "URGENT MEDICAL DEVICE RECALL" letter dated April 17, 2012 via the USPS certified mail to its consignees/customers. The firm expanded the recall on May 11, 2012 and sent a second letter entitled "EXPANDED URGENT MEDICAL DEVICE RECALL" to its affected consignees/customers notifying them of the additional issue. The letters described the product, problem and actions to be taken. The customers were instructed to return pump now; contact customer support at 1-877-229-3767 for a return goods authorization (RGA); complete and return Response Form, include RGA numbers, via Fax to Bayer Compliance at 412-4060942, and/or wait to return the pump when they begin contacting customers with this subset of pumps in August to make arrangements for a replacement pump. If you have questions, please contact our customer support team at 1-877-229-3767 or visit www.medrad.com for more information.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- FPA
- Quantity affected
- 1,229 Pumps total
- Distribution
- Worldwide distribution: USA (nationwide) and countries of: Australia, Bermuda, Brazil, Canada, China, Chile, Denmark, Dominican Republic, Estonia, Finland, France, Germany, Great Britain, Guam, Hong K
- Date initiated
- 2012-04-18
- Date posted
- 2012-12-20
- Date terminated
- 2015-08-17
- Location
- Indianola, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SET (K051499) | Medegen Medical Manufacturing Services | 2005-06-22 |