The Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda Bioactive Surface is a single-use, microporou
FDA device recall Z-0531-2015 · posted 2014-12-16 · Terminated
Recall details
- Recalling firm
- Medtronic Perfusion Systems
- Reason for recall
- Medtronic initiated an Urgent Medical Device Recall for 66 distributed Affinity FusionTM Oxygenation Systems with Carmeda Bioactive Surface due to damaged heat exchangers. Product affected by this issue is limited to model CB841 sold stand alone or incorporated in Total Systems TS1614R1 and TS1595R7. UPDATED: Recall was updated to incorporate three additional lots affected.
- Action taken
- On October 31, 2014, Medtronic field representatives began verbally notifying consignees of the issue, requesting the quarantine and return of un-used, affected product. As a follow-up to these verbal notifications, on November 12, 2014, a Medtronic "Urgent Medical Device Recall" letter dated November 2014 was hand delivered by Medtronic field personnel, and was also sent to account risk managers via UPS. The letter described the problem, the product affected by the recall and actions to be taken. Consignees were asked to immediately quarantine, remove and return all affected product to Medtronic; contact customer service at 1-800-854-3570 to initiate a return, and complete and return the attached Customer Confirmation Certificate via email to: RS.CFQFCA@Medtronic.com or fax to: Medtronic at 651-367-0612 to the attention of Customer Focused Quality. For questions they can contact their Medtronic sales representative or Lifeline Technical Services at 1-877-526-7890. UPDATE: Consignees were hand delivered an updated letter dated March 2015 concerning the additional affected product.
- Root cause
- Process control
- Status
- Terminated
- Product code
- DTZ
- Quantity affected
- 66, UPDATE: 168 additional devices.
- Distribution
- US Distribution to states of: CA and FL. UPDATED: OUS: Czech Republic and Switzerland.
- Date initiated
- 2014-10-31
- Date posted
- 2014-12-16
- Date terminated
- 2015-08-11
- Location
- Brooklyn Park, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AFFINITY FUSION CARDIOTOMY/VENOUS RESERVOIR WITH BALANCE BIOSURFACE (K132972) | Medtronic, Inc. | 2013-10-28 |
| AFFINITY FUSION OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND CARMEDA BIOACTIVE SURFACE (K123314) | Medtronic, Inc. | 2013-01-22 |