Device recall: Medtronic HY10Z48R2, Ctr., Custom Pack HY10Z48R2 Adult ECC 1/4, Custom Perfusion System, Sterile, Rx.
Class II FDA enforcement event 87915. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Specific lots may have been manufactured with insufficient or incomplete welds.
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
Medtronic Perfusion Systems started this device recall on 29 Apr 2021. The firm address in the FDA record is in Brooklyn Park, MN. FDA put the recall in Class II. FDA event 87915 has 25 product records. The first FDA enforcement report date is 23 Jun 2021. The record gives the status Terminated, with the termination date 20 Mar 2023.
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 Nationwide Distribution in the states of AL, AZ, CA, IN, KY, MA, OH, TN, and TX. There was no foreign/government/military distribution.
Recalling firm
Medtronic Perfusion Systems, Brooklyn Park, MN.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
25 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1871-2021 | Medtronic HY10Z48R2, Ctr., Custom Pack HY10Z48R2 Adult ECC 1/4, Custom Perfusion System, Sterile, Rx. | 6 tubing packs | Class II | Terminated | 23 Jun 2021 |
| Z-1872-2021 | Medtronic HY8M63R4, Custom Pack HY8M63R4 Adult ECC, Custom Perfusion System, Sterile, Rx. | 2 tubing packs | Class II | Terminated | 23 Jun 2021 |
| Z-1873-2021 | Medtronic BB10R94R6, Custom Pack BB10R94R6 1/4 ECCPK, Custom Perfusion System, Sterile, Rx. | 10 tubing packs | Class II | Terminated | 23 Jun 2021 |
| Z-1874-2021 | Medtronic BB11J14R2, Custom Pack BB11J14R2 Bridge, Custom Perfusion System, Sterile, Rx. | 15 tubing packs | Class II | Terminated | 23 Jun 2021 |
| Z-1875-2021 | Medtronic HY7M07R6, Custom Pack HY7M07R6 E 1/4, Custom Perfusion System, Sterile, Rx. | 27 tubing packs | Class II | Terminated | 23 Jun 2021 |
| Z-1876-2021 | Medtronic CB7J97R8, Custom Pack CB7J97R8 U14 E Sup, Custom Perfusion System, Sterile, Rx. | 10 tubing packs | Class II | Terminated | 23 Jun 2021 |
| Z-1877-2021 | Medtronic HY11B40R1, Custom Pack HY11B40R1 1/4 Respirato, Custom Perfusion System, Sterile, Rx. | 18 tubing packs | Class II | Terminated | 23 Jun 2021 |
| Z-1878-2021 | Medtronic CB1H18R20, Custom Pack CB1H18R20 Accesory, Custom Perfusion System, Sterile, Rx. | 4 tubing packs | Class II | Terminated | 23 Jun 2021 |
| Z-1879-2021 | Medtronic CB10W63R1, Custom Pack CB10W63R1 HL 20 1/4, Custom Perfusion System, Sterile, Rx. | 15 tubing packs | Class II | Terminated | 23 Jun 2021 |
| Z-1880-2021 | Medtronic HY8R62R13,Custom Pack HY8R62R13 E Pack, Custom Perfusion System, Sterile, Rx. | 12 tubing packs | Class II | Terminated | 23 Jun 2021 |
| Z-1881-2021 | Medtronic CB4W67R20, Custom Pack CB4W67R20 Adult E, Custom Perfusion System, Sterile, Rx. | 61 tubing packs | Class II | Terminated | 23 Jun 2021 |
| Z-1882-2021 | Medtronic CB10W64R1, Custom Pack CB10W64R1 CH Access 3/8, Custom Perfusion System, Sterile, Rx. | 12 tubing packs | Class II | Terminated | 23 Jun 2021 |
| Z-1883-2021 | Medtronic HY10J00R12, Custom Pack HY10J00R12 ECC Small CA, Custom Perfusion System, | 14 tubing packs | Class II | Terminated | 23 Jun 2021 |
| Z-1884-2021 | Medtronic CB10W65R1, Custom Pack CB10W65R1 CH Access1/4, Custom Perfusion System, Sterile, Rx. | 1 tubing pack | Class II | Terminated | 23 Jun 2021 |
| Z-1885-2021 | Medtronic HY10Y54R4, Custom Pack HY10Y54R4 ECC PED 1/4, Custom Perfusion System, Sterile, Rx. | 11 tubing packs | Class II | Terminated | 23 Jun 2021 |
| Z-1886-2021 | Medtronic HY10D90R2, Custom Pack HY10D90R2 3/8 ACC, Custom Perfusion System, Sterile, Rx. | 8 tubing packs | Class II | Terminated | 23 Jun 2021 |
| Z-1887-2021 | Medtronic CB10R79R6, Custom Pack CB10R79R6 1/4X1/4 Loop, Custom Perfusion System, Sterile, Rx. | 16 tubing packs | Class II | Terminated | 23 Jun 2021 |
| Z-1888-2021 | Medtronic CB10R55R5, Custom Pack CB10R55R5 3/8X3/8 Loop, Custom Perfusion System, Sterile, Rx. | 5 tubing packs | Class II | Terminated | 23 Jun 2021 |
| Z-1889-2021 | Medtronic CB7J98R7, Custom Pack CB7J98R7, Custom Pack CB7J98R7 3/8 Pack, Custom Perfusion System, Sterile, Rx. | 3 tubing packs | Class II | Terminated | 23 Jun 2021 |
| Z-1890-2021 | Medtronic HY10L28R3, Custom Pack HY10L28R3 1/4 Pack, Custom Perfusion System, Sterile, Rx. | 5 tubing packs | Class II | Terminated | 23 Jun 2021 |
| Z-1891-2021 | Medtronic CB10Y89R10, Custom Pack CB10Y89R10 ECC 3/8 A/V, Custom Perfusion System, Sterile, Rx. | 25 tubing packs | Class II | Terminated | 23 Jun 2021 |
| Z-1892-2021 | Medtronic BB8M63R5, Custom Pack BB8M63R5 Adult ECC, Custom Perfusion system, Sterile, Rx. | 2 tubing packs | Class II | Terminated | 23 Jun 2021 |
| Z-1893-2021 | Medtronic BB7D76R13, Custom Pack BB7D76R13 CORR HL, Custom Perfusion System, Sterile, Rx. | 26 tubing packs | Class II | Terminated | 23 Jun 2021 |
| Z-1894-2021 | Medtronic BB9G78R8, Custom Pack BB9G78R8 ECC Supp, Custom Perfusion System, Sterile, Rx. | 6 tubing packs | Class II | Terminated | 23 Jun 2021 |
| Z-1895-2021 | Medtronic 1A46R11, Custom Pack 1A46R11 Neonatal, Custom Perfusion System, Sterile, Rx. | 7 tubing sets | Class II | Terminated | 23 Jun 2021 |
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 2021
- 900
- Share of these events in Class II
- 89%
- Product records in this event
- 25Median of the firm: 1
- Events of the firm on the register
- 38
Other events of the firm
Official channels
- FDA enforcement report Z-1871-2021The 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 87915. https://recallregister.com/fda/ii/87915/. 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 Nationwide Distribution in the states of AL, AZ, CA, IN, KY, MA, OH, TN, and TX. There was no foreign/government/military distribution.
- What quantity of product is in FDA event 87915?
- The event has 25 product records. The first record gives this quantity:
6 tubing packs
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2021 have the same class?
- 89% of the 900 device events that started in 2021 are in Class II.