Device recall: Edwards Lifesciences Aortic Perfusion Cannula, 24F x 30CM, resterilized.
Class II FDA enforcement event 80317. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
SPS Sterilization, Inc started this device recall on 7 Mar 2018. The firm address in the FDA record is in Nixa, MO. FDA put the recall in Class II. FDA event 80317 has 15 product records. The first FDA enforcement report date is 19 Sep 2018. The record gives the status Terminated, with the termination date 27 Nov 2018.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
US distribution to AZ, CA, FL, OH, PA, TX, VA, WV
Recalling firm
SPS Sterilization, Inc, Nixa, MO.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
15 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-3027-2018 | Edwards Lifesciences Aortic Perfusion Cannula, 24F x 30CM, resterilized. | 10 units total | Class II | Terminated | 19 Sep 2018 |
| Z-3028-2018 | Edwards Lifesciences EZ Glide Aortic Cannula, 24F x 37.6CM, resterilized. | 6 units total | Class II | Terminated | 19 Sep 2018 |
| Z-3029-2018 | Edwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, 38FRX40CM, resterilized. | 10 units total | Class II | Terminated | 19 Sep 2018 |
| Z-3030-2018 | Edwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, 34F (11.3MM) X 40CM (16"), resterilized. | 5 units total | Class II | Terminated | 19 Sep 2018 |
| Z-3031-2018 | Edwards Lifesciences Avid Dual Stage Venous Drainage Cannula, 29/37F (9.6/12.3MM) X 37CM (14.5"), resterilized. | 5 units total | Class II | Terminated | 19 Sep 2018 |
| Z-3032-2018 | Edwards Lifesciences Femoral Venous Cannula, 18FR, resterilized. | 1 unit total | Class II | Terminated | 19 Sep 2018 |
| Z-3033-2018 | Edwards Lifesciences Femoral Venous Cannula, 20F X 55CM, resterilized. | 1 unit total | Class II | Terminated | 19 Sep 2018 |
| Z-3034-2018 | Edwards Lifesciences Optisite Arterial Perfusion Cannula, 22F X 24CM, resterilized. | 1 unit total | Class II | Terminated | 19 Sep 2018 |
| Z-3035-2018 | Boston Scientific Wallstent Endoprosthesis Tracheobronchial Transhepatic Biliary Self-Expanding Stent, 12MM X 90MM | 75CM L, resterilized. | 2 units total | Class II | Terminated | 19 Sep 2018 |
| Z-3036-2018 | Boston Scientific Wallstent Endoprosthesis Tracheobronchial Self-Expanding Stent, 22MM X 45MM | 75CM L, resterilized. | 2 units total | Class II | Terminated | 19 Sep 2018 |
| Z-3037-2018 | Boston Scientific Wallstent Endoprosthesis Tracheobronchial Self-Expanding Stent, 24MM X 70MM | 75CM L, resterilized. | 2 units total | Class II | Terminated | 19 Sep 2018 |
| Z-3038-2018 | Boston Scientific Wallstent Enteral Endoprosthesis Colonic/Duodenal Stent, 22MM X 90MM, resterilized. | 2 units total | Class II | Terminated | 19 Sep 2018 |
| Z-3039-2018 | Boston Scientific Wallstent RP Endoprosthesis Tracheobronchial Transhepatic Biliary Self-Expanding Stent, 8MM X 80MM | 75CM, resterilized. | 2 units total | Class II | Terminated | 19 Sep 2018 |
| Z-3040-2018 | Boston Scientific Wallstent RP Endoprosthesis Tracheobronchial Self-Expanding Stent, 10MM X 94MM | 135CM, resterilized. | 3 units total | Class II | Terminated | 19 Sep 2018 |
| Z-3041-2018 | Vascular Solutions Venture Rx Catheter, 6F, resterilized. | 3 units total | Class II | Terminated | 19 Sep 2018 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2018
- 1,074
- Share of these events in Class II
- 92%
- Product records in this event
- 15
- Events of the firm on the register
- 1
Official channels
- FDA enforcement report Z-3027-2018The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 80317. https://recallregister.com/fda/ii/80317/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
US distribution to AZ, CA, FL, OH, PA, TX, VA, WV
- What quantity of product is in FDA event 80317?
- The event has 15 product records. The first record gives this quantity:
10 units total
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2018 have the same class?
- 92% of the 1,074 device events that started in 2018 are in Class II.