FDA Medical Device Recalls (openFDA)
Maquet Cardiovascular Us Sales, Llc: MAQUET GETINGE GROUP Arterial Cannula OD Used to introduce blood and sterile solutions into the systemic circulation during pediatric extracorporeal circulation procedures.
- Recall number
- Z-1572-2013
- Recalling firm
- Maquet Cardiovascular Us Sales, Llc
- Product
- MAQUET GETINGE GROUP Arterial Cannula OD Used to introduce blood and sterile solutions into the systemic circulation during pediatric extracorporeal circulation procedures.
- Status
- Terminated
- Initiated
- 2013-05-14
- Posted
- 2013-06-21
- Terminated
- 2014-09-18
- Reason
- The specified part numbers and lot numbers of Maquet Pediatric Arterial Cannula Packs may contain an incorrectly sized connector.
- Root cause
- Packaging process control
- Action
- Maquet sent an "Urgent Product Recall"/"Recall - Device Corrective Action Response" forms dated May 14, 2013, via Federal Express to all affected customers. The notification identifies affected product; informs customers of the nature of the issue; advises of potential adverse patient consequences that may occur; and advises customers to follow instructions on the "Recall-Device Corrective Action Response" forms included as part of the notification. If you have any further questions please contact your local MAQUET representative or call Customer Service at (888) 627-8383.
- Quantity
- 100 units (60 Domestic; 40 International)
- Distribution
- Worldwide Distribution - US Distribution including the states of Delaware, Illinois, Minnesota , New York., Ohio and Pennsylvania and the countries of Germany, Turkey and France.
- Lot, serial or model codes
- Catalogue Number:Part Number: Lot Number are as follows: (1) 161410 (10 FR.):701022682:92056588 (2) 163610 (10 Fr):70102597:92059789 (3) 163608 (8 Fr.):70102.2681:92065640 (4) 163606 (6 Fr.):70102.2680:92063566
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FGY
- Firm FEI
- 3008355164
- 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
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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