Maquet Cardiopulmonary GmbH / Getinge Quadrox-iD Pediatric Diffusion Membrane Oxygenator with Bioline Coating, Sterile REF: BEQ-HMOD 30000
Recall
- Recall Number
- Z-0677-2020
- Event Number
- 84352
- Firm
- GETINGE US SALES LLC
- FEI Number
- 3012092534
- Product Code
- DTZ
- Status
- Open, Classified
- Root Cause
- Package design/selection
- Initiated
- November 13, 2019
- Address
- 45 BARBOUR POND DR, WAYNE, NJ, 07470
Description
Maquet Cardiopulmonary GmbH / Getinge Quadrox-iD Pediatric Diffusion Membrane Oxygenator with Bioline Coating, Sterile REF: BEQ-HMOD 30000
Sterile barrier system may be compromised
Getinge issued Urgent Medical Device Removal Letter on 11/13/19 via Fedex 2 Day delivery with Signature Proof of Delivery (SPOD) required. Letter states" Identification of Issue, Health Risk and action to take: examine your inventory immediately to determine if you have any of the lot/batch numbers listed in this recall notice. If so, please remove the affected products from areas of use and follow the instructions to return of the product to Getinge. Unused and unexpired affected product that is returned to Getinge is eligible for full credit. Affected product should be returned to Getinge. Call Maquet/Getinge Customer Support at +1(888) 627- 8383 (press option 2, then option 2), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone), to request a return material authorization (RMA) and shipping instructions to return any affected product. Complete the response form and return fax or email the completed Customer Response Form to 1-800-574-5051 OR [email protected]
Nationwide Canada
3633 US