CLASS II Device recall · Reported 23 Jun 2021 · FDA Enforcement Report

Medtronic HY11B40R1, Custom Pack HY11B40R1 1/4 Respirato recalled

Medtronic Perfusion Systems is recalling Medtronic HY11B40R1, Custom Pack HY11B40R1 1/4 Respirato, Custom Perfusion System, distributed nationwide in the US. The recall was initiated on 29 Apr 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesGTIN 00763000314231, Lot numbers 220911913, Use By 2022-03-13; and 221249923, Use By 2022-10-01

Quantity recalled18 tubing packs

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1877-2021
FDA event ID: 87915
Recalling firm: Medtronic Perfusion Systems, Brooklyn Park, MN
Classification: Class II
Status: Terminated
Recall initiated: 29 Apr 2021
FDA classified: 16 Jun 2021
Reported: 23 Jun 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

29 Apr 2021	Recall initiated by company
16 Jun 2021	Classified by FDA	+48 days
23 Jun 2021	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Specific lots may have been manufactured with insufficient or incomplete welds.

Product as listed by the FDA

Medtronic HY11B40R1, Custom Pack HY11B40R1 1/4 Respirato, Custom Perfusion System, Sterile, Rx.

Where it was distributed

US Nationwide Distribution in the states of AL, AZ, CA, IN, KY, MA, OH, TN, and TX. There was no foreign/government/military distribution.

Nationwide Alabama Arizona California Indiana Kentucky Massachusetts Ohio Tennessee Texas

Questions about this recall

Why was it recalled?

Specific lots may have been manufactured with insufficient or incomplete welds.

Which lots are affected?

GTIN 00763000314231, Lot numbers 220911913, Use By 2022-03-13; and 221249923, Use By 2022-10-01

Where was it sold?

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 should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

24 other products · FDA event 87915

This product is part of a recall event; the main page for the event is Medtronic HY10L28R3, Custom Pack HY10L28R3 recalled.

Reported	Class	Recall	Company	Reason	Where
23 Jun 2021	CLASS II	Medtronic HY10L28R3, Custom Pack HY10L28R3 recalled	Medtronic Perfusion Systems	Other	Nationwide
23 Jun 2021	CLASS II	Medtronic CB10Y89R10, Custom Pack CB10Y89R10 ECC 3/8 A/V recalled	Medtronic Perfusion Systems	Other	Nationwide
23 Jun 2021	CLASS II	Medtronic CB10W64R1, Custom Pack CB10W64R1 CH Access 3/8 recalled	Medtronic Perfusion Systems	Other	Nationwide
23 Jun 2021	CLASS II	Medtronic CB10W63R1, Custom Pack CB10W63R1 HL 20 1/4 recalled	Medtronic Perfusion Systems	Other	Nationwide
23 Jun 2021	CLASS II	Medtronic BB8M63R5, Custom Pack BB8M63R5 Adult ECC recalled	Medtronic Perfusion Systems	Other	Nationwide
23 Jun 2021	CLASS II	Medtronic BB10R94R6, Custom Pack BB10R94R6 1/4 Eccpk recalled	Medtronic Perfusion Systems	Other	Nationwide
23 Jun 2021	CLASS II	Medtronic CB7J98R7, Custom Pack CB7J98R7 recalled	Medtronic Perfusion Systems	Other	Nationwide
23 Jun 2021	CLASS II	Medtronic CB4W67R20, Custom Pack CB4W67R20 Adult E recalled	Medtronic Perfusion Systems	Other	Nationwide
23 Jun 2021	CLASS II	Medtronic CB10R79R6, Custom Pack CB10R79R6 1//4 Loop recalled	Medtronic Perfusion Systems	Other	Nationwide
23 Jun 2021	CLASS II	Medtronic HY10Z48R2, Ctr., Custom Pack HY10Z48R2 Adult ECC recalled	Medtronic Perfusion Systems	Other	Nationwide
23 Jun 2021	CLASS II	Medtronic CB7J97R8, Custom Pack CB7J97R8 U14 E Sup recalled	Medtronic Perfusion Systems	Other	Nationwide
23 Jun 2021	CLASS II	Medtronic BB11J14R2, Custom Pack BB11J14R2 Bridge recalled	Medtronic Perfusion Systems	Other	Nationwide
23 Jun 2021	CLASS II	Medtronic BB9G78R8, Custom Pack BB9G78R8 ECC Supp recalled	Medtronic Perfusion Systems	Other	Nationwide
23 Jun 2021	CLASS II	Medtronic CB10W65R1, Custom Pack CB10W65R1 CH Access1/4 recalled	Medtronic Perfusion Systems	Other	Nationwide
23 Jun 2021	CLASS II	Medtronic HY10D90R2, Custom Pack HY10D90R2 3/8 ACC recalled	Medtronic Perfusion Systems	Other	Nationwide
23 Jun 2021	CLASS II	Medtronic BB7D76R13, Custom Pack BB7D76R13 CORR HL recalled	Medtronic Perfusion Systems	Other	Nationwide
23 Jun 2021	CLASS II	Medtronic HY10J00R12, Custom Pack HY10J00R12 ECC Small CA recalled	Medtronic Perfusion Systems	Other	Nationwide
23 Jun 2021	CLASS II	Medtronic HY10Y54R4, Custom Pack HY10Y54R4 ECC PED 1/4 recalled	Medtronic Perfusion Systems	Other	Nationwide
23 Jun 2021	CLASS II	Medtronic CB10R55R5, Custom Pack CB10R55R5 3//8 Loop recalled	Medtronic Perfusion Systems	Other	Nationwide
23 Jun 2021	CLASS II	Medtronic 1A46R11, Custom Pack 1A46R11 Neonatal recalled	Medtronic Perfusion Systems	Other	Nationwide
23 Jun 2021	CLASS II	Medtronic HY7M07R6, Custom Pack HY7M07R6 E 1/4 recalled	Medtronic Perfusion Systems	Other	Nationwide
23 Jun 2021	CLASS II	Medtronic CB1H18R20, Custom Pack CB1H18R20 Accesory recalled	Medtronic Perfusion Systems	Other	Nationwide
23 Jun 2021	CLASS II	Medtronic HY8M63R4, Custom Pack HY8M63R4 Adult ECC recalled	Medtronic Perfusion Systems	Other	Nationwide
23 Jun 2021	CLASS II	Medtronic HY8R62R13,Custom Pack HY8R62R13 E Pack recalled	Medtronic Perfusion Systems	Other	Nationwide

More recalls from Medtronic Perfusion Systems

All 116

Reported	Class	Recall	Company	Reason	Where
5 Aug 2026Device	CLASS II	Eopa Elongated One-Piece Arterial Cannula Blunt recalled	Medtronic Perfusion Systems	Packaging Defects	Nationwide
5 Aug 2026Device	CLASS II	EOPA Elongated One-Piece Arterial Cannula DIL TIP recalled	Medtronic Perfusion Systems	Packaging Defects	Nationwide
5 Aug 2026Device	CLASS II	Eopa Elongated One-Piece Arterial Cannula Blunt recalled	Medtronic Perfusion Systems	Packaging Defects	Nationwide
5 Aug 2026Device	CLASS II	EOPA 3D Arterial Cannula DIL TIP, intended for use recalled	Medtronic Perfusion Systems	Packaging Defects	Nationwide
5 Aug 2026Device	CLASS II	EOPA 3D Arterial Cannula, intended for use recalled	Medtronic Perfusion Systems	Packaging Defects	Nationwide

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All 13,778

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16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide