FDA Medical Device Recalls (openFDA)
Maquet Cardiovascular, LLC: Maquet Getinge-BEQ-TOP 33500 3/8" ECC PACK Material: 701053752
- Recall number
- Z-1527-2019
- Recalling firm
- Maquet Cardiovascular, LLC
- Product
- Maquet Getinge-BEQ-TOP 33500 3/8" ECC PACK Material: 701053752
- Status
- Terminated
- Initiated
- 2019-04-18
- Posted
- 2019-05-31
- Terminated
- 2025-07-28
- Reason
- 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
- Root cause
- Device Design
- Action
- 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.
- Quantity
- not on file
- Distribution
- Nationwide
- Lot, serial or model codes
- Batch Numbers: 3000056255
- 510(k) numbers
- ["K080592"]
- PMA numbers
- not on file
- Product code
- DWF
- Firm FEI
- 2242352
- Firm city
- Wayne
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28