Maquet Cardiopulmonary GmbH / Getinge Quadrox-iD Pediatric Diffusion Membrane Oxygenator with Bioline Coating, Sterile REF: BEQ-HMOD 30000
- Company
- Getinge Us Sales Llc
- Recall Initiated
- November 13, 2019
- Recall Number
- Z-0677-2020
- Quantity
- 3633 US
- Firm Location
- WAYNE, NJ
Reason for Recall
Sterile barrier system may be compromised
Distribution
Nationwide Canada
Lot / Code Info
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
Root Cause
Package design/selection
Action Taken
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