Recall Z-0677-2020 ยท DTZ Oxygenator, Cardiopulmonary Bypass
GETINGE US SALES LLC
Maquet Cardiopulmonary GmbH / Getinge Quadrox-iD Pediatric Diffusion Membrane Oxygenator with Bioline Coating, Sterile REF: BEQ-HMOD 30000
| Date | Nov 13, 2019 |
| Status | Open, Classified |
| Reason | Sterile barrier system may be compromised |
| Root cause | Package design/selection |
| Action | 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. |
| Quantity | 3633 US |
| Distribution | Nationwide Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100278 | QUADROX-ID PEDIATRIC DIFFUSION MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODELS BE-HMOD 30000-USA, BEQ-HMOD 30000-USA Maquet Cardiopulmonary, AG, Apr 30, 2010 |