GETINGE US SALES LLC Maquet Cardiopulmonary GmbH / Getinge Quadrox-iD Pediatric Diffusion Membrane Oxygenator with Bioline Coating, Sterile REF: BEQ-HMOD 30000 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Maquet Cardiopulmonary GmbH / Getinge Quadrox-iD Pediatric Diffusion Membrane Oxygenator with Bioline Coating, Sterile REF: BEQ-HMOD 30000
Brand
GETINGE US SALES LLC
Lot Codes / Batch Numbers
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
Products Sold
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
GETINGE US SALES LLC is recalling Maquet Cardiopulmonary GmbH / Getinge Quadrox-iD Pediatric Diffusion Membrane Oxygenator with Biolin due to Sterile barrier system may be compromised. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Sterile barrier system may be compromised
Recommended Action
Per FDA guidance
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 QuadroxiDPediatricFA.US@getinge.com
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026