Z-0677-2020Class II

Maquet Cardiopulmonary GmbH / Getinge Quadrox-iD Pediatric Diffusion Membrane Oxygenator with Bioline...

Name: Z-0677-2020 Maquet Cardiopulmonary GmbH / Getinge Quadrox-iD Pediatric Diffusion Membrane Oxygenator with Bioline...
Creator: Getinge US Sales Llc
Published: 2019-11-13
License: https://open.fda.gov/license/

Getinge US Sales LLC / initiated 2019-11-13 / Open, Classified / root cause: packaging

FDA source

GETINGE US SALES LLC began a recall of Maquet Cardiopulmonary GmbH / Getinge Quadrox-iD Pediatric Diffusion Membrane Oxygenator with Bioline Coating, Sterile REF: BEQ-HMOD 30000 on 2019-11-13. FDA classified it as Class II and gives the reason as "Sterile barrier system may be compromised". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0677-2020
Classification: Class II
Status: Open, Classified
Initiated: 2019-11-13
Posted: 2019-12-12
Recalling firm: Getinge US Sales LLC
Product: Maquet Cardiopulmonary GmbH / Getinge Quadrox-iD Pediatric Diffusion Membrane Oxygenator with Bioline Coating, Sterile REF: BEQ-HMOD 30000
Product code: DTZ Oxygenator, Cardiopulmonary Bypass
Reason for recall: Sterile barrier system may be compromised
Root cause tag: packaging
FDA 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. 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]
Quantity in commerce: 3633 US
Distribution: Nationwide Canada
Product codes and lots: Lot codes: 70114704, 70120471, 70123847, 70123854, 70124528, 70124693, 70127336, 70130216, 70123853, 70129395, 7011472 05, 70121444, 70123849, 70124474, 70124529, 70124694, 70127498, 70131871, 70124527, 70113694, 70120282, 70121445, 70123850, 70124525, 70124689, 70124695, 70127499, 70120470, 70124692, 70120283, 70121668, 70123852, 70124526, 70124691, 70124696, 70128623, 70122004, 70127335 UDI Code: 04037691670164

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0677-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0677-2020	Class II	Ongoing	Voluntary: Firm initiated	2019-12-18	2019-12-12

Product code DTZ

K100278Class IIQuadrox-Id Pediatric Diffusion Membrane Oxygenator with Bioline Coating, Models Be-Hmod 30000-USA, Beq-Hmod 30000-USAMaquet Cardiopulmonary, AG / cleared 2010-04-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)