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Medtronic CB10W65R1, Custom Pack CB10W65R1 CH Access1/4… recallZ-1884-2021 · Medtronic Perfusion Systems · initiated Apr 29, 2021

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Medtronic Perfusion Systems or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Nonconforming Material/Component

What the company is doing

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].

Recall details

Recall number
Z-1884-2021
Status
Terminated
Initiated by the company
Apr 29, 2021
Recalling firm
Medtronic Perfusion Systems
Quantity
1 tubing pack
Product code
DWF
FDA submissions
K171979
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 description

Medtronic CB10W65R1, Custom Pack CB10W65R1 CH Access1/4, Custom Perfusion System, Sterile, Rx.

Code information (models, lots, serial numbers)

GTIN 00763000341022, Lot number 221332879, Use By 2022-10-05

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

340 devices cleared under K171979 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 87915).

Sources and updates

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