Z-1891-2021Class II

Medtronic CB10Y89R10, Custom Pack CB10Y89R10 ECC 3/8 A/V, Custom Perfusion System, Sterile, Rx

Name: Z-1891-2021 Medtronic CB10Y89R10, Custom Pack CB10Y89R10 ECC 3/8 A/V, Custom Perfusion System, Sterile, Rx
Creator: Medtronic Perfusion Systems
Published: 2021-04-29
License: https://open.fda.gov/license/

Medtronic Perfusion Systems / initiated 2021-04-29 / Terminated / root cause: manufacturing process

FDA source

Medtronic Perfusion Systems began a recall of Medtronic CB10Y89R10, Custom Pack CB10Y89R10 ECC 3/8 A/V, Custom Perfusion System, Sterile, Rx on 2021-04-29. FDA classified it as Class II and gives the reason as "Specific lots may have been manufactured with insufficient or incomplete welds". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1891-2021
Classification: Class II
Status: Terminated
Initiated: 2021-04-29
Posted: 2021-06-16
Terminated: 2023-03-20
Recalling firm: Medtronic Perfusion Systems
Product: Medtronic CB10Y89R10, Custom Pack CB10Y89R10 ECC 3/8 A/V, Custom Perfusion System, Sterile, Rx.
Product code: DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Reason for recall: Specific lots may have been manufactured with insufficient or incomplete welds.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Medtronic notified customers by letters dated April 202, via 2-day UPS delivery to consignees explaining the reason for recall and requesting they immediately identify and quarantine all unused product in their inventory. The product was to be returned. A Customer Confirmation Certificate was enclosed for completion via scan and email. If product was further distributed or transferred, the consignee was requested to notify those downstream customers or facilities of the recall. For questions regarding this notification, customers were instructed to contact Smiths Medical via email at [email protected].
Quantity in commerce: 25 tubing packs
Distribution: US Nationwide Distribution in the states of AL, AZ, CA, IN, KY, MA, OH, TN, and TX. There was no foreign/government/military distribution.
Product codes and lots: GTIN 00763000499105, Lot numbers 221719701, Use By 2023-01-06; and 221764442, Use By 2023-01-13

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1891-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1871-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-23	2021-06-16
Z-1872-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-23	2021-06-16
Z-1873-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-23	2021-06-16
Z-1874-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-23	2021-06-16
Z-1875-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-23	2021-06-16
Z-1876-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-23	2021-06-16
Z-1877-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-23	2021-06-16
Z-1878-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-23	2021-06-16
Z-1879-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-23	2021-06-16
Z-1880-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-23	2021-06-16
Z-1881-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-23	2021-06-16
Z-1882-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-23	2021-06-16
Z-1883-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-23	2021-06-16
Z-1884-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-23	2021-06-16
Z-1885-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-23	2021-06-16
Z-1886-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-23	2021-06-16
Z-1887-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-23	2021-06-16
Z-1888-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-23	2021-06-16
Z-1889-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-23	2021-06-16
Z-1890-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-23	2021-06-16
Z-1891-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-23	2021-06-16
Z-1892-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-23	2021-06-16
Z-1893-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-23	2021-06-16
Z-1894-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-23	2021-06-16
Z-1895-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-23	2021-06-16

Product code DWF

K171979Class IITubing PackMedtronic, Inc. / cleared 2017-10-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)