Maquet Getinge-BO-T 41301 BUMC ECC PACK Material: 701065209
FDA device recall Z-1568-2019 · posted 2019-05-31 · Terminated
Recall details
- Recalling firm
- Maquet Cardiovascular, LLC
- Reason for recall
- Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
- Action taken
- Maquet Getinge issued recall notification letter on April 18, 2019 via FedEx 2-day delivery identifies issue, health risk and action to take: quarantine and return to Maquet/Getinge recalled product. Complete response form and return to acknowledge this recall. Questions contact Getinge Customer Service at 1 888 627 8383 (press option 2, then option 2) between the hours of 8 AM and 6 PM Eastern Standard Time. On 3/26/20 firm expanded recall to include an additional lot for one consignee,product: "BEQ TOP 25003 3/8 3/8 up to 7 lpm", item number 701063255R02, lot 3000087051.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- DWF
- Distribution
- Nationwide
- Date initiated
- 2019-04-18
- Date posted
- 2019-05-31
- Date terminated
- 2025-07-28
- Location
- Wayne, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HLM TUBING SET WITH BIOLINE COATING (K080592) | Maquet Cardiopulmonary, AG | 2008-09-11 |