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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 72550

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
October 28, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Medtronic Perfusion Systems

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

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Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

Medtronic Perfusion Tubing Packs, Models TL7M64R3, TL7P17R1 & HY2W85R9, Sterilized using Ethylene Oxide. The Tubing Pack design and components are specified by the user, they are packaged with consideration of setup efficiency and respect for the environment, and they are intended for use in the extracorporeal circuit during cardiopulmonary bypass procedures. Medtronic Tubing Packs can contain components with Carmeda BioActive Surface, Trillium BioSurface, Balance BioSurface or no coating. Sterile barrier for these packs is provided either by a Tyvek lid seal on the tray or by a header bag.

Z-0268-2016
Recall number
Z-0268-2016
Initiated
October 28, 2015
Classification
Class II
Status
Terminated
Quantity
496

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
This recall is being initiated due to a potential breach of the Tubing Pack Header Bags manufactured in these select lots. The seal in question is between the Tyvek and the Poly side of the header bag.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

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Inspect official wording and provenance

Reason for recall

This recall is being initiated due to a potential breach of the Tubing Pack Header Bags manufactured in these select lots. The seal in question is between the Tyvek and the Poly side of the header bag.

Code information

Model Lot Numbers Lot Number HY2W85R9 209704344,209704345,209704346, 209704347,210010558 TL7M64R3 209789393 TL7P17R1 209789333

Distribution pattern

Nationwide Distribution including US: AL, IL, IN, and WI.