Z-0268-2016 Class II Terminated
FDA device recall Z-0268-2016 was initiated by Medtronic Perfusion Systems on Oct 28, 2015 and is designated Class II. 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… The recall status is terminated (terminated Aug 17, 2016). Affected quantity: 496.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 18, 2015
- Initiation Date
- Oct 28, 2015
- Termination Date
- Aug 17, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 496
Product Description
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.
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.
Distribution Pattern
Nationwide Distribution including US: AL, IL, IN, and WI.
Code Information
Model Lot Numbers Lot Number HY2W85R9 209704344,209704345,209704346, 209704347,210010558 TL7M64R3 209789393 TL7P17R1 209789333
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0268-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026